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Arthrex® AR-8967DGRecalls & reported problems

Arthrex, Inc. · CANN DEPTH DEV FOR 6.7 MM CANN SCRWS · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867056725), received between Aug 5, 2024 and Aug 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 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: 1 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: 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

  • Defective Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 5, 2024Defective Device; Defective Device

    IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE K-WIRE WON'T PASS THROUGH THE CANNULATED TIP OF THE DEVICE. THE SURGEON THEN USED ANOTHER K-WIRE TO MEASURE THE LENGTH. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 23-JUL-2024: IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE AR-8967DG LOOKS DAMAGED. THE K-WIRE USED WITH THE DEVICE WAS AR-8967KTS. [07:45] (B)(6). UPDATE DW 30-JUL-2024: FURTHER INFORMATION WAS PROVIDED THAT DUE TO THE DAMAGED DEPTH GAUGE THE SURGEON USED ANOTHER K-WIRE AGAINST THE INSERTED K-WIRE TO CALCULATE THE LENGTH OF SCREW NEEDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19906133 ↗

Other GAUGE, DEPTH devices

All GAUGE, DEPTH devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.