Reported Reactions

Devices › Suture, nonabsorbable, synthetic, polyethylene

Device brand name · Suture nonabsorbable synthetic polyethylene

Meniscal Cinch: medical device reports filed with FDA

178 reports name it, 2008–2026. Manufacturer given most often on reports: Arthrex. Product code GAT.

178
device reports naming the brand
0% of all MAUDE reports · about 10 a year
18
reports, 12 months to August 2026
7 in the 12 months before
38.2%
classified as malfunction
72.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 178 reports that name the brand "Meniscal Cinch" (suture nonabsorbable synthetic polyethylene), received between November 2008 and May 2026; the manufacturer given most often on reports is Arthrex. Spellings of one product vary from report to report.

18 reports arrived in the 12 months to August 2026, up 157% from 7 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 (51.7%), malfunction (38.2%) and other (10.1%); across all suture, nonabsorbable, synthetic, polyethylene reports (product code GAT) death is recorded in 0.2% and malfunction in 72.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (14%), positioning failure (11.8%) and detachment of device or device component (5.6%). The patient problems coded most often are device embedded in tissue or plaque, foreign body in patient and failure of implant. 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."

Reports by month, five years

0713Sep 2021: 2Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 4Aug 2022: 0Sep 2022: 2Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 2Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 3Sep 2023: 1Oct 2023: 0Nov 2023: 0Dec 2023: 12024Jan 2024: 1Feb 2024: 3Mar 2024: 1Apr 2024: 4May 2024: 5Jun 2024: 12Jul 2024: 2Aug 2024: 0Sep 2024: 1Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 2May 2025: 4Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 13Oct 2025: 2Nov 2025: 0Dec 2025: 02026Jan 2026: 1Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 2Jun 2026: 0Jul 2026: 0Aug 2026: 0

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

015292008: 520082009: 202012: 420122013: 32014: 1420142015: 112016: 1020162017: 122018: 420182019: 112020: 920202021: 92022: 620222023: 72024: 2920242025: 212026: 32026

Event type and report source

Event type, as classified on the report

Death0%0
Injury51.7%92
Malfunction38.2%68
Other10.1%18
Not given0%0

Who filed the report

Manufacturer report100%178
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 20,369 reports carrying product code GAT. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke2514%15.8%
Positioning failure2111.8%3.8%
Detachment of device or device componentpart of the device came off105.6%3.1%
Physical resistance/sticking95.1%3.3%
Device dislodged or dislocated84.5%9.1%
Detachment of device component73.9%1.5%
Device slipped42.2%0.5%
Failure to advance42.2%1.2%
Device operates differently than expectedthe device behaved unexpectedly31.7%1.7%
Difficult to insertthe device was hard to insert31.7%0.1%
Failure to fire31.7%18.1%
Loose or intermittent connection31.7%0.5%
Sticking31.7%0.3%
Activation, positioning or separation problem21.1%4.2%
Insufficient device problem information21.1%1%
Material twisted/bent21.1%1.6%
Mechanical jam21.1%0.3%
Activation problem10.6%0.3%
Component falling10.6%0.6%
Cut in material10.6%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Device embedded in tissue or plaque105.6%
Foreign body in patientpart of a device left in the patient52.8%
Failure of implant10.6%
Needle stick/puncture10.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureMeniscal CinchProduct code GATAll MAUDE reports
Reports17820,36926,136,888
Share of that pool—0.9%0%
Classified as death, per 1,000 reports029
Classified as injury51.7%26.9%36.2%
Classified as malfunction38.2%72.7%62.3%
Filed by the manufacturer100%98.9%94.9%

Shares are of reports, not 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."

Other brands with product code GAT

BrandReportsLatest 12 monthsClassified as death
Fast-Fix 360 Curved Ndl Delivery Sys8,2991,7550%
Ultra Fast-Fix Assembly - Curved1,093640%
Ethibond Extra & Excel Polyester Suture Unknown719321.3%
Fast-Fix 360 Reversed Curve Ndl Deliv6911090%
Ff Flex Crvd Instr5613250%
Fast-Fix 360 Curved Ndl Dlvry Sys Ei44800%
Fast Fix Flx Crvd Insrtr Bndr Cann Set4321670%
V-Loc366720%
Ultra Fast-Fix Ab Assembly - Curved30590%
Ti-Cron237280.4%
Mersilene Polyester Fiber Suture Unknown Product19741.5%
Eb Exc Grn 36in 4-0 D/A Rb-1186140%
Fast-Fix 360 Straight Ndl Delivery Sy159100%
Fst Fix Flx Rev Crvd Insrtr Bndr Cann St152500%
ETHIBOND Extra & Excel Polyester Suture317340%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Meniscal Cinch reports

How many FDA reports name Meniscal Cinch?

178 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 18 in the latest 12 months.

What kinds of events are reported?

injury (51.7%), malfunction (38.2%) and other (10.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (14%), positioning failure (11.8%), detachment of device or device component (5.6%), physical resistance/sticking (5.1%) and device dislodged or dislocated (4.5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Meniscal Cinch was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.