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Arthrex® AR-8737-16Recalls & reported problems

Arthrex, Inc. · DRIVER SHAFT, T10 HEXALOBE, CANNULATED · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867046115), received between Apr 7, 2021 and Oct 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 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: 1 reportsNov 2025: 0 reportsDec 2025: 0 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

  • Break2
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-16 DRIVER TWISTED UP WHILE THE HCP WAS PUTTING IN THE SCREWS. A DIFFERENT DRIVER WAS BROUGHT IN TO COMPLETE THE CASE. NO TIME WAS ADDED TO THE CASE, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23304456 ↗
  • MalfunctionJun 12, 2023Break; Break

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-16 AND AN AR-8737-25 , 2.4 AND 3.0 CANNULATED DRIVERS BROKE DURING A CASE DUE TO WEAR AND TEAR. PATIENT WAS NOT AFFECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17112354 ↗
  • MalfunctionApr 7, 2021Break

    IT WAS REPORTED THAT THE TIP OF THE AR-8737-16 BROKE OFF DURING INSERTION. THE SALES REP REPORTED ALL BROKEN FRAGMENTS WERE FULLY RETRIEVED. THERE WAS NO NEGATIVE OUTCOME, AND THE CASE WAS COMPLETED BY USING ANOTHER DRIVER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11627302 ↗

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Sources and updates

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