Arthrex® AR-1938BCSRecalls & reported problems
Arthrex, Inc. · BC Knotless SutureTak, Open Repair · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867287365), received between Mar 2, 2021 and Sep 8, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Failure to Advance1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2023Break; Break
ON 8/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1938BCS BIOCOMPOSITE KNOTLESS SUTURETAK REPAIR AND SHUTTING SUTURES WERE SWEDGED TOGETHER. THE ANCHOR DID NOT SHUTTLE AND BROKE OFF. THE ANCHOR WAS LEFT INSIDE THE PATIENT, AND THE FRAGMENTS WERE NOT RETRIEVED. THIS WAS DISCOVERED DURING A LATERAL EPICONDYLE REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 17711508 ↗MalfunctionMar 2, 2021Failure to Advance
IT WAS REPORTED DURING AN ELBOW REPAIR THE SUTURE WOULD NOT PASS THROUGH THE ANCHOR. THE SURGEON WAS ABLE TO SECURE THE ANCHOR WITH A SINGLE SUTURE. HE WAS NOT ABLE TO USE THE KNOTLESS PROCESS. ALL WAS SECURE AND THE PATIENT IS FINE TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11398320 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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