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NA 357.112Recalls & reported problems

Synthes (U.S.A.) LP · INSERTION HANDLE FOR DISTAL FEMORAL NAILS · 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 10886982195845), received between Jan 19, 2017 and Jan 19, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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.

Most reported problems

Device problems

  • Failure to Align1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 19, 2017Failure to Align; Failure to Align

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT SURGERY FOR THE FEMORAL DIAPHYSEAL FRACTURE. DURING THE SURGERY, THE SURGEON REAMED THE MEDULLARY CAVITY 1.5MM OVER THE REQUIRED DIAMETER. NEXT, HE TESTED SIDE STOPPAGE WITH A LONG NAIL IN A DRIED CONDITION AND SUCCEEDED IN THE TEST. THEN, HE INSERTED THE NAIL. BY SETTING THE STANDARD LOCKING MODE, HE STARTED THE SIDE STOPPAGE WITH LOCKING SCREWS ON THE DISTAL LOCATION. BY USING A BATTERY HANDPIECE HE TRIED ANOTHER SIDE STOPPAGE WITH A 4.9MM SCREW ON THE PROXIMAL LOCATION. BECAUSE HE WANTED TO EXTEND THE PATIENT¿S KNEE, THE SURGEON SET ASIDE AN AIMING ARM. NEXT, HE INSERTED AN END CAP. FINALLY, HE RE-STARTED THE SIDE STOPPAGE. DURING THE FINAL CHECK WITH IMAGES, THE SURGEON FOUND THAT THE 6.0MM SCREW ON THE MOST DISTAL LOCATION HAD NOT BEEN PROPERLY INSERTED INTO THE SIDE-STOPPAGE HOLE OF THE NAIL. AS A MATTER OF FACT, THE SCREW WAS INSERTED CLOSE TO THE FOREFRONT OF THE NAIL. THEREFORE THERE IS A POSSIBILITY TO REMAIN THE SCAR. THEN HE REMOVED THE SCREW. WITHOUT USING THE AIMING ARM, HE DRILLED MANUALLY AND TOOK MEASUREMENTS AGAIN. HE USED A 7.0MM SCREW AN

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6264866 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.