Arthrex® AR-8936BC-CPRecalls & reported problems
Arthrex, Inc. · IMP SYS, ARTHREX BROSTROM REPAIR · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867051263), received between Mar 10, 2017 and Dec 8, 2025 — classified as 3 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Device Slipped1
Patient problems
- Insufficient Information2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE ARTHROSCOPIC REPAIR OF THE LATERAL LIGAMENT ACCORDING TO BROSTROM (ARTHROBROSTROM TECHNIQUE) THE SUTURES DISENGANGE FROM BOTH ANCHORS OF THE KIT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH ANOTHER PART NUMBER (AR-1902SF). IT WAS NECESSARY TO CHANGE THE SURGICAL TECHNIQUE FROM ARTHROSCOPIC TO OPEN SURGERY. A SECOND OPERATION WAS NOT NECESSARY.
Patient problems: Insufficient Information
MAUDE report 23742350 ↗InjuryJan 14, 2021Device Slipped
IT WAS REPORTED THAT DURING A DEX PROCEDURE, THE SURGEON USED AR-8936BC-CP, AND ONE OF THE 3.0 ANCHORS CAME COMPLETELY OUT OF THE BROCADED HOLE AND ALL THE REPAIR WAS LOST. A DIFFERENT DEVICE WAS USED AS THE SURGEON HAD TO SWITCH TO ANOTHER TECHNIQUE TO COMPLETE THE CASE. ADDITIONAL INFORMATION PROVIDE 12/9/2020: THE SURGEON HAD TO REVERT TO AN OPEN PROCEDURE IN ORDER TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 11170504 ↗InjuryMar 10, 2017Break; Detachment Of Device Component
IT WAS REPORTED THAT THE ARTHREX BROSTROM REPAIR IMPLANT SYSTEM WAS BEING USED IN A BROSTOM REPAIR PROCEDURE. WHILE USING THE CANNULATED DRILL THAT IS INCLUDED IN THE KIT TO DRILL A BONE TUNNEL, THE TIP OF THE DRILL BROKE OFF. THE TIP OF THE DRILL BIT WAS PULLED OUT OF THE POSTERIOR ASPECT OF THE FIBULA WHEN DOING PERONEAL TENDON REPAIR AS ADJUNCT TO LATERAL ANKLE STABILIZATION. THE SECOND INCISION WAS EXTENDED SLIGHTLY TO GET ACCESS TO WHERE THE DRILL TIP WAS IN ORDER TO REMOVE IT. NO BROKEN PIECES REMAIN IN THE PATIENT. A SECOND ARTHREX BROSTOM REPAIR IMPLANT SYSTEM WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY REPORTED.
Patient problems: No Code Available
MAUDE report 6394887 ↗
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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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