Tray, surgical, instrument: medical device reports filed with FDA

2,280 reports carry this product code, 1992–2026; 13 brands with a page.

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.

2,280
reports with this product code: 0% of all MAUDE reports; 389
reports, 12 months to August 2026: 245 in the 12 months before; 94.5%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code FSM is FDA's classification for "Tray, surgical, instrument" (general, Plastic Surgery panel), a class 1 device. 2,280 medical device reports carry this product code, 0% of the MAUDE database, from April 1992 to August 2026.

389 reports arrived in the 12 months to August 2026, up 59% from 245 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 (94.5%), injury (5%) and other (0.2%). 13 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Electric Pen Drive 60 000 Rpm	10	94	0%	99.1%
Epd 60000 Rpm	8	0	0%	99.2%
Colibri	4	0	0%	100%
Eleos	4	2	0.1%	4.9%
Custom Pak	3	0	0%	74.1%
Deroyal	2	14	0.7%	72.7%
Attune Fb Tib Base Sz 4 Cem	1	14	0%	1.5%
Orthopedic Manual Surgical Instrument	1	0	0.2%	85.9%
Power Drive	1	0	0%	99.8%
Quickset Ace Grater Head 59mm	1	9	0%	100%
Quickset Ace Grater Head 61mm	1	0	0%	100%
Unknown Knee Tibial Tray	1	57	0.2%	3%
Ventralight ST Mesh	1	106	0.5%	1.8%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Depuy Ireland - 3015516266	473	20.7%
Depuy Synthes Power Tools	41	1.8%
Depuy France Sas - 3003895575	10	0.4%
Synthes Oberdorf	7	0.3%
Onkos Surgical	4	0.2%
Acumed	3	0.1%
Paragon 28	3	0.1%
Stryker Instruments	3	0.1%
Deroyal Industries	2	0.1%
Ponce - Uss	2	0.1%
Aesculap	1	0%
Bd Caribe	1	0%
Cardinal Health 200	1	0%
Davol Sub C R Bard -1213643	1	0%
Exactech	1	0%

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 and report source

Event type

Death0.1%2

Injury5%114

Malfunction94.5%2,154

Other0.2%4

Not given0.3%6

Who filed

Manufacturer report96.6%2,202

Voluntary report1.3%29

User facility report0%0

Distributor report0.1%2

Not given2.1%47

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Peeled/delaminated	1,019	44.7%
Breakthe device broke	387	17%
Contamination /decontamination problem	197	8.6%
Crackthe device cracked	183	8%
Naturally worn	109	4.8%
Delamination	100	4.4%
Material discolored	53	2.3%
Material twisted/bent	52	2.3%
Flaked	47	2.1%
Fracturea broken bone	41	1.8%
Corrodedthe device corroded	35	1.5%
Material deformation	32	1.4%
Device operates differently than expectedthe device behaved unexpectedly	27	1.2%
Material integrity problema problem with the device material	26	1.1%
Device inoperablethe device could not be used	25	1.1%
Unsealed device packaging	23	1%
Tear, rip or hole in device packaging	22	1%
Material fragmentation	21	0.9%
Scratched material	20	0.9%
Incorrect measurementthe device measured wrongly	19	0.8%

Questions about tray, surgical, instrument reports

What is product code FSM?

FDA's classification code for "Tray, surgical, instrument", class 1, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,280 reports through August 2026, 389 of them in the latest 12 months.

Which brands appear most often?

Electric Pen Drive 60 000 Rpm (10), Epd 60000 Rpm (8), Colibri (4), Eleos (4) and Custom Pak (3). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.