NA SD03.043.030Recalls & reported problems
Synthes GmbH · THREADED ALIGNMENT PIN ROTATING TNA AIMING ARM · Class 1
- 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 10886982344359), received between Oct 1, 2024 and Oct 1, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
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.
MalfunctionOct 1, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE ISSUES WITH SOME DEVICES. THE AIMING ARM IS INTENDED TO BE USED TO TARGET THE SCREWS IN THE PROXIMAL PORTION OF THE NAIL. HOWEVER, THE AIMING ARM MISSED THE HOLE IN THE TNA NAIL. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR A THREADED ALIGNMENT PIN ROTATING TNA AIMING ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344510 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.