Arthrex® AR-1934PS-1Recalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, PEEK SUTURE TAK · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867024175), received between Mar 29, 2024 and Mar 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SHOULDER RECONSTRUCTION THE ANCHOR FELL OUT OF THE CANAL. THE CANAL WAS PROPERLY PREPARED WITH A DEDICATED DRILL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT 20-APR-2022: THE ANCHOR DID NOT HOLD IN THE CANAL AND THEREFORE IT FELL OUT. AN AR-1934PS-2-1 LOT 10280327 WAS USED TO FINISH THE SURGERY SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19005901 ↗
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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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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