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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

Other FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE devices

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Sources and updates

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