Arthrex® AR-1938PSSRecalls & reported problems
Arthrex, Inc. · PEEK 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 00888867290778), received between Nov 7, 2022 and May 9, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information1
- 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.
MalfunctionMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 11/23/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1938PSS PEEK KNOTLESS SUTURETAK ANCHOR AND AN AR-1941PS PEEK KNOTLESS CORKSCREW ANCHOR, PULLED OUT FROM IMPLANTATION SITE. THIS WAS DISCOVERED DURING AN MPFL RECONSTRUCTION PROCEDURE ON (B)(6) 2021. WHEN SURGEON IMPLANTED BOTH SUTURETAK, THE ANCHORS PULLED OUT WITHOUT ANY RESISTANCE. THEN, SURGEON REMOVED THE SUTURETAK ANCHORS AND SWAPPED IT FOR THE CORKSCREW ANCHOR BUT IT ALSO PULLED OUT WITHOUT RESISTANCE. FINALLY, THE SURGEON HAD TO DRILL A BONE TUNNEL TO ACHIEVE ADEQUATE FIXATION AND COMPLETE CASE. AFTER RECEIVING ADDITIONAL INFORMATION ON 11/30/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT ALL THREE FAILED ANCHORS WERE REMOVED FROM THE PATIENT AND THERE WAS NOT BROKEN PIECES LEFT TO RETRIEVED. SURGEON COMPLETED PROCEDURE SUCCESSFULLY AND PATIENT WAS NOT AFFECTED.
Patient problems: Insufficient Information
MAUDE report 19278866 ↗MalfunctionNov 7, 2022Break
ON 10/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1938PSS PEEK KNOTLESS SUTURETAK ANCHOR BROKE OFF DURING INSERTION. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. ALL BROKEN FRAGMENTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15743156 ↗
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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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