BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFN Ø12 LE L380 TAN

    MDR report key: 3230339 · Received July 16, 2013

    Report

    Report Number
    2520274-2013-04477
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    May 5, 2012
    Report Date
    May 11, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED AND THE TIP OF THE DRILL WAS FOUND BLUNT. ALL INSTRUMENTS HAVE BEEN TESTED AND ARE FULLY FUNCTIONAL. THEY ALSO HAVE BEEN MEASURED AND FOUND TO BE ACCORDING THE GIVEN SPECIFICATION. ONLY THE TIP OF THE DRILL WAS FOUND BLUNT. THERE IS EVIDENCE THAT THE PRESSURE FROM THE SOFT TISSUE ONTO THE PROTECTION SLEEVE MAY HAVE LED TO THE MISALIGNMENT. NO PRODUCT FAULT COULD BE DETECTED. THE LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROPHYLACTIC NAILING OF THE FEMUR WITH RECON LOCKING, UPON OPENING OF THE FEMORAL IM CANAL, THE REAMING RIA AND THE NAIL INSERTION WERE UNEVENTFUL PER THE RECOMMENDED TECHNIQUE. WHEN THE CAUDAL RECON SCREW GUIDE WIRE WAS INSERTED, IT WAS RETROVERTED AND REMOVED. THE INSERTION HANDLE WAS REPOSITIONED TO PROVIDE MORE CENTRAL POSITION IN THE FEMORAL HEAD FOR THE RECON SCREWS. WHEN REINSERTED THE GUIDE WIRE DID NOT TRAVERSE THE LOCKING HOLE OF THE NAIL, PASSING POSTERIOR TO THE NAIL IN THE FEMORAL NECK. THE CAUDAL WIRE WAS REMOVED AND THE CRANIAL WIRE WAS INSERTED WITH GOOD POSITIONING. THE RIGID REAMER WAS USED IN THE CAUDAL SCREW HOLE. THE SCREW WAS REMOVED DUE TO THE SCREW MISSING THE NAIL. THE CAUDAL SCREW HOLD WAS REAMED AGAIN, THE REAMER STRUCK THE NAIL AND WAS UNABLE TO PASS THE SCREW CANNULATION. THE AIMING ARM WAS TORSIONED MANUALLY BY THE SURGEON. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328985 AFN Ø12 LE L380 TAN HSB SYNTHES USA 2043564

    Patients

    Seq Age Sex Outcome Treatment
    1