NA 5300010063Recalls & reported problems
Stryker Corporation · 1.5mm Wire Pass Drill Medium · Class 1
- 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 07613153000037), received between Mar 29, 2021 and Mar 29, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
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.
InjuryMar 29, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING AN OSTEOPLASTY PROCEDURE, THE BUR BROKE AND THE FRAGMENT LOGGED IN THE PATIENT¿S SOFT TISSUE. IT WAS FURTHER REPORTED THAT THE SURGEON RETRIEVED THE BROKEN FRAGMENT WHICH RESULTED IN A THIRTY MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581378 ↗
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- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.