Device manufacturer, as written on reports

Wrights Lane Synthes USA Products: medical device reports filed with FDA

27,430 reports name it as the manufacturer of the device involved, 2017–2024.

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.

27,430
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 2 in the 12 months before; 47.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

27,430 medical device reports received by FDA give Wrights Lane Synthes USA Products as the manufacturer of the device involved, 0.1% of the MAUDE database, from April 2017 to October 2024. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, against 2 in 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 injury (52.1%) and malfunction (47.9%). 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
UNK - Screws: Trauma	Screw, fixation, bone	868	288	0%
UNK - Screws: Locking	Screw, fixation, bone	775	98	0%
Unk - Screws Cortex	Screw, fixation, bone	597	16	0%
Driving Cap/Threaded	Orthopedic manual surgical instrument	510	58	0%
Depth Gauge For 2 0mm And 2 4mm Screws	Gauge, depth	509	68	0%
Ti Locking Screw	Posterior cervical screw system	259	0	0%
5mm Hex Flexible Screwdriver	Orthopedic manual surgical instrument	195	60	0.2%
Unk - Plates	Plate, fixation, bone	184	0	0%
Stardrive Scrwdrvr Shft/T4 50mm/Self-Retaining/Hxc	Screwdriver	164	16	0%
Torque Limiting Handle/Quick Release-6mm Hex Coupling	Screwdriver	161	0	0%
Blade/Screw Guide Sleeve	Guide, surgical, instrument	115	40	0%
UNK - Constructs: Plate/Screws	Plate, fixation, bone	113	9	0%
Unk - Screws 3 5 Mm Cortex	Screw, fixation, bone	110	33	0%
Driving Cap	Orthopedic manual surgical instrument	109	65	0%
Drive Shaft-Minimum 520mm Length-For Use With Ria	Reamer	105	0	0.2%
Stardrive Screwdriver Shaft T8 105mm	Screwdriver	98	43	0%
Ti Matrixneuro Screw Self-Drilling 4mm	Plate, bone	97	74	0%
Small Hexagonal Screwdriver With Holding Sleeve	Screwdriver	95	0	0%
UNK - Nails: TFNA	Rod, fixation, intramedullary and accessories	94	24	0%
Handle With Quick Coupling Small	Tap, bone	89	16	0%
Unk - Screws	Screw, fixation, bone	82	0	0%
Hand Piece For Battery Powered Driver	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	74	66	0%
UNK - Screws: Nail Distal Locking	Screw, fixation, bone	72	12	0.2%
Radiolucent Insertion Handle Frn	Rod, fixation, intramedullary and accessories	68	14	0%
Unk - Screws 5 0 Mm Locking	Screw, fixation, bone	67	14	0%
Application Instrument For Sternal Zipfix	Cerclage, fixation	62	4	0%
6mm/9mm Cannulated Stepped Drill Bit	Bit, drill	55	23	0%
5 0mm Flexible Shaft	Reamer	52	2	0%
Cannulated 4 0mm Hexagonal Screwdriver	Screwdriver	51	9	0%
Aiming Arm/ Radiolucent	Nail, fixation, bone	50	82	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
HWC	Screw, fixation, bone	6,426	23.4%
HSB	Rod, fixation, intramedullary and accessories	2,689	9.8%
LXH	Orthopedic manual surgical instrument	2,419	8.8%
HXX	Screwdriver	2,401	8.8%
HRS	Plate, fixation, bone	2,316	8.4%
FZX	Guide, surgical, instrument	1,229	4.5%
HTJ	Gauge, depth	879	3.2%
HTO	Reamer	831	3%
KTT	Appliance, fixation, nail/blade/plate combination, multiple component	619	2.3%
JDS	Nail, fixation, bone	503	1.8%

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%4

Injury52.1%14,290

Malfunction47.9%13,136

Other0%0

Not given0%0

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

Questions about Wrights Lane Synthes USA Products reports

How many FDA device reports name Wrights Lane Synthes USA Products as manufacturer?

27,430 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

UNK - Screws: Trauma (868), UNK - Screws: Locking (775), Unk - Screws Cortex (597), Driving Cap/Threaded (510) and Depth Gauge For 2 0mm And 2 4mm Screws (509).

Which device types does it report on?

screw, fixation, bone (23.4%), rod, fixation, intramedullary and accessories (9.8%), orthopedic manual surgical instrument (8.8%) and screwdriver (8.8%).

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.