Arthrex® AR-8980BC-1Recalls & reported problems
Arthrex, Inc. · Sutr Anch, DX SwvLk, BC, 1/pack, 4.7 mm · Class 2 · Implant
Data updated Oct 18, 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 00888867319875), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Material Deformation1
Patient problems
- Insufficient Information1
- 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.
MalfunctionSep 15, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
ON 8/26/2025, AN EMPLOYEE FROM AN ARTHREX SUBSIDIARY REPORTED VIA EMAIL AN ISSUE INVOLVING THE AR-8980BC-1 SWIVELOCK DX DURING A PL TENDON FIXATION PROCEDURE ON (B)(6) 2025. AFTER THE DEVICE WAS INSERTED, IT DISLODGED FROM THE BONE SOCKET WHILE THE EYELET SUTURE WAS BEING REMOVED. THE TIP OF THE SCREW WAS FOUND TO BE DEFORMED AND DAMAGED, RENDERING IT UNUSABLE. DESPITE THE COMPLICATION, THE TAPE AND PL TENDON WERE SUCCESSFULLY SUTURED TO THE JOINT CAPSULE, AND THE OPERATION WAS COMPLETED WITHOUT FURTHER INCIDENT AS THE PATIENT¿S CONDITION STABILIZED. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE BONE SOCKET HAD BEEN DRILLED USING A 2.4 GUIDE PIN AND A 4.5 HOLLOW DRILL, WITHOUT THE USE OF A TAP. BONE QUALITY WAS NOTED TO BE HARD.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23053989 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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