Device manufacturer, as written on reports

Synthes Monument: medical device reports filed with FDA

8,871 reports name it as the manufacturer of the device involved, 2007–2018.

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.

8,871
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 56.9%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

8,871 medical device reports received by FDA give Synthes Monument as the manufacturer of the device involved, 0% of the MAUDE database, from December 2007 to January 2018. 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 malfunction (56.9%), injury (42.7%) 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
Hand Piece For Battery Powered Driver	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	238	66	0%
Holding Sleeve-Long For Matrix	Orthopedic manual surgical instrument	238	3	0%
Drive Shaft-Minimum 520mm Length-For Use With Ria	Reamer	226	0	0.2%
Cable Tensioner	Orthopedic manual surgical instrument	170	0	0%
Depth Gauge For 2 0mm And 2 4mm Screws	Gauge, depth	95	68	0%
Ti Matrixneuro Screw Self-Drilling 4mm	Plate, bone	89	74	0%
T25 Stardrive Shaft F/Matrix Long	Screwdriver	81	6	0%
Helical Blade Coupling Screw	Orthopedic manual surgical instrument	60	0	0%
2 5mm Drill Bit/Qc/Gold/110mm	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	59	14	0%
Ti Locking Screw	Posterior cervical screw system	48	0	0%
Ti Low Profile Neuro Screw Self-Drilling 4mm	Plate, bone	35	4	0%
Helical Blade Inserter	Orthopedic manual surgical instrument	24	8	0%
3 5mm Cortex Screw Self-Tapping 14mm	Screw, fixation, bone	23	0	0%
Stardrive Scrwdrvr Shft/T4 50mm/Self-Retaining/Hxc	Screwdriver	20	16	0%
8 5mm Medullary Reamer Head	Reamer	19	6	0%
Stardrive Screwdriver Shaft T8 105mm	Screwdriver	19	43	0%
Dhs/Dcs Coupling Screw	Extractor	17	12	0%
Sternal Zipfix With Needle Sterile	Cerclage, fixation	11	12	0%
Ni	Set, administration, for peritoneal dialysis, disposable	8	1,587	1.8%

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
LXH	Orthopedic manual surgical instrument	1,142	12.9%
HWC	Screw, fixation, bone	1,056	11.9%
HXX	Screwdriver	969	10.9%
HSB	Rod, fixation, intramedullary and accessories	953	10.7%
HTO	Reamer	520	5.9%
JEY	Plate, bone	429	4.8%
HRS	Plate, fixation, bone	345	3.9%
FZX	Guide, surgical, instrument	291	3.3%
JDS	Nail, fixation, bone	242	2.7%
HTW	Bit, drill	227	2.6%

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%18

Injury42.7%3,792

Malfunction56.9%5,046

Other0%0

Not given0.2%15

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

Questions about Synthes Monument reports

How many FDA device reports name Synthes Monument as manufacturer?

8,871 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Hand Piece For Battery Powered Driver (238), Holding Sleeve-Long For Matrix (238), Drive Shaft-Minimum 520mm Length-For Use With Ria (226), Cable Tensioner (170) and Depth Gauge For 2 0mm And 2 4mm Screws (95).

Which device types does it report on?

orthopedic manual surgical instrument (12.9%), screw, fixation, bone (11.9%), screwdriver (10.9%) and rod, fixation, intramedullary and accessories (10.7%).

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.