NA 704006-20Recalls & reported problems
Stryker GmbH · Barrel Reamer Assembly Short · Class 1
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 07613153054481), received between May 29, 2025 and May 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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
- Device Damaged Prior to Receipt by User1
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.
MalfunctionMay 29, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
AS REPORTED: "WHEN OPENING THE BOX (CONSIGNMENT PRODUCT) DURING THE SURGERY, THE DRILL BIT OF THE OMEGA CEPHALIC SCREW WAS MISSING. THE OPERATION TOOK A LONG TIME WITH THE CONSEQUENT RISK FOR THE PATIENT. AS AN ALTERNATIVE, MATERIAL FROM ANOTHER COMMERCIAL COMPANY WAS SOUGHT. IT HAD TO BE STERILIZED AND IMPLANTED, ALL OF THIS TOOK SOME TIME BUT THE SURGERY WAS COMPLETED. TO DATE, NO ADVERSE EFFECTS HAVE BEEN REPORTED IN THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105945 ↗
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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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