NA 355.44Recalls & reported problems
Synthes GmbH · THREADED CONICAL BOLT FOR 10MM-14MM UNIV TIBIAL NAILS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982194985), received between Aug 14, 2019 and Feb 2, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).
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-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING LOAN KIT INSPECTION, THE TWO PRODUCTS IN QUESTION WERE FOUND TO BE STUCK TOGETHER. THE TECHNICIAN WAS UNABLE TO PULL THEM APART. THERE WAS NO PROCEDURE OR PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A THREADED CONICAL BOLT FOR 10MM-14MM UNIV TIBIAL NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18632684 ↗MalfunctionAug 14, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2019, DURING EVALUATION IN THE LOANER DEPARTMENT, IT WAS FOUND THAT THREADED CONICAL BOLT WAS NOT FUNCTIONING AND STUCK TO A NON DEPUY SYNTHES PRODUCT PART NUMBER 04.004.049. THERE WAS NO PATIENT INVOLVEMENT THIS REPORT IS FOR ONE (1) THREADED CONICAL BOLT FOR 10 MM-14 MM UNIV TIBIAL NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8893305 ↗
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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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