NA 357.396Recalls & reported problems
Synthes GmbH · EXTRACTION SCREW F/TROCHANTERIC FIXATION 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 10886982196217), received between Aug 30, 2022 and Oct 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE REMOVAL OF A TFNA OCCURRED WHERE THE EXTRACTOR WAS CROSS THREADED, SO A TFN EXTRACTOR WAS USED. THE HELICAL BLADE EXTRACTOR FROM TFN WAS USED DUE TO THE TFNA BLADE EXTRACTOR BEING DROPPED. THE BLADE WAS COLD WELDED. THE FLEXIBLE SCREWDRIVER WAS CROSS THREADED WHILE UNLOCKING SET SCREW. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND IF FRAGMENTS WERE GENERATED OR NOT. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385085 ↗MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE THAT, TWO NAIL REMOVAL INSTRUMENTS ARE STUCK TOGETHER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) EXTRACTION SCR F/TFN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15319593 ↗
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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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