Device manufacturer, as written on reports

Synthes USA: medical device reports filed with FDA

34,093 reports name it as the manufacturer of the device involved, 1992–2023.

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.

34,093
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 24.3%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

34,093 medical device reports received by FDA give Synthes USA as the manufacturer of the device involved, 0.1% of the MAUDE database, from June 1992 to December 2023. 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, and none 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 (75.3%), malfunction (24.3%) and death (0.2%). 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
Ni	Set, administration, for peritoneal dialysis, disposable	584	1,587	1.8%
Screw	Screw, fixation, bone	496	0	0%
Ti Nut 11mm Width Across Flats	Orthosis, spondylolisthesis spinal fixation	179	0	0%
Locking Screw	Screw, fixation, bone	175	3	0%
Ti Matrixneuro Screw Self-Drilling 4mm	Plate, bone	159	74	0%
Ti Collar With Grooves	Orthosis, spondylolisthesis spinal fixation	138	0	0%
Synthes	Plate, fixation, bone	112	0	0.6%
Ti 12-Point Nut-11mm	Thoracolumbosacral pedicle screw system	96	0	0%
Ti Matrix Locking Cap	Thoracolumbosacral pedicle screw system	74	0	1.2%
Ti Matrixneuro Screw Self-Drilling 5mm	Plate, bone	72	50	0%
Ti Low Profile Neuro Screw Self-Drilling 4mm	Plate, bone	60	4	0%
Ti Locking Screw	Posterior cervical screw system	55	0	0%
Small Battery Drive	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	52	0	0%
3 5mm Cortex Screw Self-Tapping 14mm	Screw, fixation, bone	33	0	0%
2 5mm Drill Bit/Qc/Gold/110mm	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	32	14	0%
8 5mm Medullary Reamer Head	Reamer	25	6	0%
Helical Blade Coupling Screw	Orthopedic manual surgical instrument	25	0	0%
2 0mm Drill Bit With Depth Mark/Qc/140mm	Bit, drill	23	19	0%
Electric Pen Drive 60 000 Rpm	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	15	94	0%
3 2mm Guide Wire 400mm	Orthopedic manual surgical instrument	14	7	0%
5 0mm Flexible Shaft	Reamer	13	2	0%
T-Pal Spacer Applicator Handle	Intervertebral fusion device with bone graft, lumbar	9	0	0%
T-Pal Spacer Applicator Inner Shaft	Intervertebral fusion device with bone graft, lumbar	9	0	0%
Handle With Quick Coupling Small	Tap, bone	8	16	0%
Drive Shaft-Minimum 520mm Length-For Use With Ria	Reamer	6	0	0.2%
Depth Gauge For 2 7mm & Small Screws	Gauge, depth	5	5	0%
Depth Gauge For 2 0mm And 2 4mm Screws	Gauge, depth	4	68	0%
Universal Chuck With T-Handle	Orthopedic manual surgical instrument	4	9	0%
Cannulated Connecting Screw	Rod, fixation, intramedullary and accessories	3	27	0%
Drill Bit	Bit, drill	3	25	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	9,855	28.9%
HRS	Plate, fixation, bone	6,076	17.8%
HSB	Rod, fixation, intramedullary and accessories	1,909	5.6%
NKB	Thoracolumbosacral pedicle screw system	1,661	4.9%
JEY	Plate, bone	1,294	3.8%
KWQ	Appliance, fixation, spinal intervertebral body	1,093	3.2%
JDS	Nail, fixation, bone	961	2.8%
KTT	Appliance, fixation, nail/blade/plate combination, multiple component	945	2.8%
KWP	Appliance, fixation, spinal interlaminal	662	1.9%
MNI	Orthosis, spinal pedicle fixation	589	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

Death0.2%61

Injury75.3%25,675

Malfunction24.3%8,276

Other0.1%36

Not given0.1%45

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

Questions about Synthes USA reports

How many FDA device reports name Synthes USA as manufacturer?

34,093 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Ni (584), Screw (496), Ti Nut 11mm Width Across Flats (179), Locking Screw (175) and Ti Matrixneuro Screw Self-Drilling 4mm (159).

Which device types does it report on?

screw, fixation, bone (28.9%), plate, fixation, bone (17.8%), rod, fixation, intramedullary and accessories (5.6%) and thoracolumbosacral pedicle screw system (4.9%).

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.