NA 04.032.105SRecalls & reported problems
Synthes GmbH · 11.0MM TI TROCH FIXATION NAIL SCREW/105MM - STERILE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10886982094865), received between Jan 9, 2019 and Jan 9, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION OF THE HIP. DURING THE REMOVAL, THE TITANIUM TROCHANTERIC FIXATION NAIL SCREW, TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, AND TITANIUM LOCKING SCREW WITH T25 STARDRIVE WERE REMOVED. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TITANIUM TROCHANTERIC FIXATION NAIL SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8232420 ↗
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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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