Arthrex® AR-8980DSRecalls & reported problems
Arthrex, Inc. · Disposable Kit for DX Swivelock, 4.75 mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867319851), received between Nov 22, 2023 and Nov 22, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Component Misassembled” (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
- Component Misassembled1
- Patient Device Interaction Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2023Patient Device Interaction Problem; Component Misassembled; Patient Device Interaction Problem; Component Misassembled
ON 31ST OCTOBER 2023, IT WAS REPORTED BY A SALES REP. VIA EMAIL THAT AN AR-8980DS, DISPOSABLE KIT FOR DX SWIVELOCK®, 4.75MM, WAS FAULTY AS IT HAD A COMPLETELY SQUARED TIP INSTEAD OF A POINTY TIP, WAS NOT DRILLING THROUGH BONE AND WAS CAUSING HEAT BUILDUP AND SOME BURNING OF BONE EDGES THROUGH FRICTION. THIS WAS DISCOVERED DURING USE IN A ACHILLES RECONSTRUCTION ON 27TH OCTOBER 2023. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DRILL KIT WITH THE SAME LOT NUMBER.
Patient problems: Burn(s)
MAUDE report 18192005 ↗
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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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