NA 60-15008Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Drill for 8mm Screws, Stryker Shaft · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07613154184002), received between Nov 14, 2023 and Nov 14, 2023 — classified as 1 malfunction.
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. 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
- 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.
MalfunctionNov 14, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL BROKE OFF INTO THE PATIENT BONE. THE BROKEN PIECE REMAINS IN PATIENT BONE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136316 ↗
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- MIDAS REX MR8 MR8-AA10Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)192 reports
- Midas Rex MR8 MR8-AF02Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)189 reports
- NA 5407-FA2-000Stryker Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)181 reports
- Indigo™ 1845000Medtronic Xomed, Inc. · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)165 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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