Arthrex® AR-8980BCRecalls & reported problems
Arthrex, Inc. · DX Knotless SwiveLock, BC, 4.75 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867319868), received between Apr 10, 2024 and Sep 20, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8980BC DX KNOTLESS SWIVELOCK, AN AR-8913DS MINI TIGHTROPE, AND AN AR-7237-7 FIBERTAPE COULD NOT BE EASILY IMPLANTED. THE PATIENT'S BONE WAS HARD, SO THE SURGEON TAPPED THE IMPLANTS IN WITH A MALLET TO PLACE THEM IN THE TUNNEL. THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE ON (B)(6) 2024. ONE TO TWO WEEKS LATER, ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE ALL THE PRODUCTS EXPLANTED. THE AR-8980BC DX KNOTLESS SWIVELOCK ANCHOR HAD PULLED OUT OF THE MEDIAL CUNEIFORM BONE. THE LISFRANC LIGAMENT PLASTY PROCEDURE WAS COMPLETED USING AN AR-8913DS MINI TIGHTROPE FROM LOT NUMBER 15242118, AN AR-7237-7 FIBERTAPE FROM LOT NUMBER 15081694, AND AN AR-8922 SUTURE BUTTON FROM LOT NUMBER 15166049.
Patient problems: Failure of Implant
MAUDE report 20268246 ↗MalfunctionApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8980BC DX KNOTLESS SWIVELOCK ANCHOR SLID INTO THE SHAFT AND PULLED OUT WHEN SHAFT WAS REMOVED FROM THE PATIENT. SURGEON TAPPED AGAIN AND USED AN AR-2324PSLC PEEK-SWIVELOCK, WHICH THE ANCHOR ALSO SLID INTO THE DRIVER SHAFT AND PULLED OUT WHEN IT WAS REMOVED. FINALLY, AN AR-1540PS PEEK TENODESIS SCREW WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PATELLA TENDON REPAIR PROCEDURE ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 19080693 ↗
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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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