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Arthrex® AR-8970-03Recalls & reported problems

Arthrex, Inc. · T20 HEXALOBE DRIVER · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867133747), received between Feb 3, 2026 and Feb 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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

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: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Dull, Blunt2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 3, 2026Dull, Blunt

    IT WAS REPORTED THAT DURING A SURGERY THE SCREWDRIVERS WERE HEAVILY WORN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 14-JAN-2026: THE REPORTED DEVICES ARRIVED AT ARTHREX GMBH AND DURING AN INITIAL INSPECTION OF THE DEVICES IT WAS NOTICES THAT THE TIP OF THE DEVICE AR-8970-03 (LOT: 1392436) IS BROKEN OFF. UPDATE 27-JAN-2026: IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT AND THE DEVICE MIGHT HAVE BROKEN DURING SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24251575 ↗
  • MalfunctionFeb 3, 2026Dull, Blunt

    IT WAS REPORTED THAT DURING A SURGERY THE SCREWDRIVERS WERE HEAVILY WORN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24251573 ↗

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Sources and updates

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