Suture, nonabsorbable, synthetic, polyamide: medical device reports filed with FDA

6,142 reports carry this product code, 1996–2026; 10 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.

6,142
reports with this product code: 0% of all MAUDE reports; 1,056
reports, 12 months to August 2026: 701 in the 12 months before; 84.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code GAR is FDA's classification for "Suture, nonabsorbable, synthetic, polyamide" (general, Plastic Surgery panel), a class 2 device. 6,142 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to August 2026.

1,056 reports arrived in the 12 months to August 2026, up 51% from 701 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 (84.9%), injury (14.7%) and other (0.2%). 10 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
Monosof	410	89	0%	90%
ETHILON Nylon Suture	328	9	0.2%	47.6%
Alcon Closure System (ACS), Nylon	323	152	0%	90.1%
Ethilon Nylon Suture Unknown Product	191	6	0.5%	5.8%
Ethilon	181	183	0%	98.4%
Non Absorbable Surgical Suture	90	39	0%	96.4%
McKesson	17	74	0%	89.7%
Unknown Suture Product	3	28	0.9%	45.3%
ETHIBOND Extra & Excel Polyester Suture	1	34	0%	24.9%
Surgicel Absorbable Hemostat	1	0	2.1%	0.7%

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
Ethicon	4,050	65.9%
B Braun Surgical	582	9.5%
Davis & Geck Caribe	556	9.1%
Alcon Research - Alcon Precision Device	329	5.4%
United States Surgical	56	0.9%
Covidien North Haven	27	0.4%
Covidien Surgical	17	0.3%
Alcon Laboratories	10	0.2%
North Haven - Uss	3	0%
Aesculap	2	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%2

Injury14.7%904

Malfunction84.9%5,215

Other0.2%14

Not given0.1%7

Who filed

Manufacturer report98.8%6,066

Voluntary report0.7%44

User facility report0%0

Distributor report0%0

Not given0.5%32

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	2,797	45.5%
Material separation	1,309	21.3%
Detachment of device or device componentpart of the device came off	351	5.7%
Dull, blunt	183	3%
Material split, cut or torn	135	2.2%
Detachment of device component	83	1.4%
Product quality problem	80	1.3%
Device markings/labelling problema problem with the device markings or label	70	1.1%
Device contaminated during manufacture or shipping	69	1.1%
Other (for use when an appropriate device code cannot be identified)	68	1.1%
Suture line disruption	63	1%
Defective component	62	1%
Manufacturing, packaging or shipping problem	61	1%
Component misassembled	59	1%
Material integrity problema problem with the device material	50	0.8%
Reactiona reaction, type not specified	42	0.7%
Failure to adhere or bond	40	0.7%
Delivered as unsterile product	37	0.6%
Material frayed	33	0.5%
Material twisted/bent	30	0.5%

Questions about suture, nonabsorbable, synthetic, polyamide reports

What is product code GAR?

FDA's classification code for "Suture, nonabsorbable, synthetic, polyamide", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

6,142 reports through August 2026, 1,056 of them in the latest 12 months.

Which brands appear most often?

Monosof (410), ETHILON Nylon Suture (328), Alcon Closure System (ACS), Nylon (323), Ethilon Nylon Suture Unknown Product (191) and Ethilon (181). 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.