Device manufacturer, as written on reports

Smith & Nephew: medical device reports filed with FDA

85,841 reports name it as the manufacturer of the device involved, 1997–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

85,841
reports naming it as manufacturer: 0.3% of all MAUDE reports; 6,481
reports, 12 months to August 2026: 6,257 in the 12 months before; 62.3%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

85,841 medical device reports received by FDA give Smith & Nephew as the manufacturer of the device involved, 0.3% of the MAUDE database, from February 1997 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

6,481 reports arrived in the 12 months to August 2026, close to the 6,257 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (62.3%), injury (37.5%) and other (0.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Fast-Fix 360 Curved Ndl Delivery Sys	Suture, nonabsorbable, synthetic, polyethylene	8,282	1,755	0%
Motor Drive Unit Hand Cntrl Pwrmx El	Saw, powered, and accessories	5,181	208	0%
Svc Repl Mdu Hand Cntrl Pwrmx	Saw, powered, and accessories	1,229	24	0%
Ultra Fast-Fix Assembly - Curved	Suture, nonabsorbable, synthetic, polyethylene	1,085	64	0%
Footprint Ultra Pk Suture Anchor 4 5	Fastener, fixation, nondegradable, soft tissue	930	147	0%
Femoral Implant Impactor	Prosthesis, hip, femoral component, cemented, metal	681	18	0%
Fast-Fix 360 Reversed Curve Ndl Deliv	Suture, nonabsorbable, synthetic, polyethylene	617	109	0%
Ff Flex Crvd Instr	Suture, nonabsorbable, synthetic, polyethylene	537	325	0%
R3 Straight Shell Impactor	Orthopedic manual surgical instrument	511	21	0%
Healicoil Knotless Pk Nst	Fastener, fixation, nondegradable, soft tissue	463	140	0%
Ruler	Tape, measuring, rulers and calipers	461	6	0%
Fast-Fix 360 Curved Ndl Dlvry Sys Ei	Suture, nonabsorbable, synthetic, polyethylene	438	0	0%
Fast Fix Flx Crvd Insrtr Bndr Cann Set	Suture, nonabsorbable, synthetic, polyethylene	420	167	0%
R3 Offset Impactor Tip	Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer	418	44	0%
Mi Z Handle Acet Reamer	Prosthesis, hip, femoral component, cemented, metal	415	22	0%
R3 Offset Impactor	Prosthesis, hip, femoral component, cemented, metal	415	35	0%
Twinfix Ultra Pk 4 5mm W/2 Ub -Wht &bl	Fastener, fixation, nondegradable, soft tissue	399	59	0%
Knee Implant	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	396	0	0%
Spider 2 Tenet 7615	Table, operating-room, electrical	370	5	0%
Rdce Frcps W/ Pts Brd	Prosthesis, hip, femoral component, cemented, metal	353	1	0%
T-Handle	Prosthesis, hip, femoral component, cemented, metal	292	17	0%
Healicoil Knotless Rgnst	Fastener, fixation, biodegradable, soft tissue	272	108	0%
Trauma Implant	Nail, fixation, bone	264	0	0.4%
Hip Implant	Prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal	238	0	1.1%
Journey Fem Impact Bumper Lt	Orthopedic manual surgical instrument	237	8	0%
Dii Controller	Arthroscope	235	6	0%
Twinfix Ultra Ha 4 5 W/2 Ub Wh & Blue	Fastener, fixation, biodegradable, soft tissue	221	56	0%
Journey Fem Impact Bumper Rt	Orthopedic manual surgical instrument	214	10	0%
Osteoraptor 2 9 W/ 2 Ub White / Blue	Fastener, fixation, biodegradable, soft tissue	204	55	0%
Bhr	Prosthesis, hip, semi-constrained, metal/metal, resurfacing	198	0	0%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	13,111	15.3%
GAT	Suture, nonabsorbable, synthetic, polyethylene	12,849	15%
HAB	Saw, powered, and accessories	8,871	10.3%
MBI	Fastener, fixation, nondegradable, soft tissue	5,549	6.5%
JDG	Prosthesis, hip, femoral component, cemented, metal	3,976	4.6%
HRY	Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer	3,167	3.7%
LXH	Orthopedic manual surgical instrument	2,911	3.4%
HSB	Rod, fixation, intramedullary and accessories	2,204	2.6%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	1,740	2%
JDH	Prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal	1,477	1.7%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.1%46

Injury37.5%32,154

Malfunction62.3%53,481

Other0.1%82

Not given0.1%78

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Smith & Nephew reports

How many FDA device reports name Smith & Nephew as manufacturer?

85,841 reports through August 2026, 6,481 of them in the latest 12 months.

Which of its brands appear most often?

Fast-Fix 360 Curved Ndl Delivery Sys (8,282), Motor Drive Unit Hand Cntrl Pwrmx El (5,181), Svc Repl Mdu Hand Cntrl Pwrmx (1,229), Ultra Fast-Fix Assembly - Curved (1,085) and Footprint Ultra Pk Suture Anchor 4 5 (930).

Which device types does it report on?

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (15.3%), suture, nonabsorbable, synthetic, polyethylene (15%), saw, powered, and accessories (10.3%) and fastener, fixation, nondegradable, soft tissue (6.5%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.