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
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
- NA 319.006Synthes GmbH · GAUGE, DEPTH899 reports
- NA 03.133.080Synthes GmbH · GAUGE, DEPTH174 reports
- NA 03.010.072Synthes GmbH · GAUGE, DEPTH133 reports
- MULTILOC 03.019.017Synthes GmbH · GAUGE, DEPTH119 reports
- NA 319.01Synthes GmbH · GAUGE, DEPTH113 reports
- NA 319.004Synthes GmbH · GAUGE, DEPTH82 reports
- QUICKSET 2274-60-000Depuy (Ireland) · GAUGE, DEPTH68 reports
- NA 319.09Synthes GmbH · GAUGE, DEPTH65 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.