Arthrex® AR-3600NDSR-1Recalls & reported problems
Arthrex, Inc. · 1.6MM FIBER TAK SHAVERDRILL · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867239463), received between Aug 29, 2025 and Aug 29, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
- 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.
InjuryAug 29, 2025Break; Break
IT WAS REPORTED THAT AFTER A SURGERY, THE POST-OPERATIVE X-RAY SHOWED A DRILL TIP STILL REMAINING IN THE PATIENT, WHICH WASN¿T REALISED DURING THE OPERATION. AN ADDITIONAL SURGERY WAS REQUIRED TO REMOVE THE BROKEN DRILL TIP. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. ***UPDATE C MACKENBACH 20-AUG*** ADDITIONAL INFORMATION WAS PROVIDED THAT THE ORIGINAL SURGERY DATE WAS A LATARJET PROCEDURE ON (B)(6) -2025 AND THE REVISION SURGERY DATE WAS ON (B)(6) 2025.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22924328 ↗
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- NA 05.001.223Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT397 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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