BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3845027 · Received June 3, 2014

    Report

    Report Number
    3003875359-2014-10155
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; ONE STANDARD INSERTION HANDLE WAS RETURNED WITH A COMPLAINT CATEGORY OF; DOES NOT/ WILL NOT FUNCTION: BENDS. THE STANDARD INSERTION HANDLE IS PART OF TITANIUM LATERAL ENTRY FEMORAL RECON NAILING SYSTEM WHICH IS USED IN THE INSERTION OF THE FEMORAL NAIL-EX. THE INFORMATION IS PROVIDED PER THE TITANIUM LATERAL ENTRY FEMORAL RECON NAILING TECHNIQUE GUIDE. THE STANDARD INSERTION HANDLE WAS RECEIVED WITH MULTIPLE HAMMER MARKS ON THE BOTTOM SIDE OF THE HANDLE AROUND THE EDGE OF THE 120 DEGREES ANTEGRADE INSERTION HOLE. ALSO, THE ETCHING ON THE HANDLE IS FADING AWAY. THE EDGES AROUND THE 120 DEGREES ANTEGRADE INSERTION HOLE ARE ROLLED OVER REDUCING THE DIAMETER OF THE HOLE AND CAUSING THE INSERTION HANDLE 03.010.063 TO GET STUCK OR JAMMED WHEN INSERTED. THE RETURNED DEVICE WAS MATED WITH PART #03.010.063 AND VERIFIED THAT THE PART GETS STUCK/JAMMED IN THE 120 DEGREE ANTEGRADE HOLE. THE BALANCE OF THE INSTRUMENT IS IN GOOD CONDITION. A REVIEW OF THE DESIGN DRAWING INDICATES THAT THE RETURNED PART WAS MANUFACTURED TO DRAWING SPECIFICATIONS SINCE THEN THERE WERE THREE UPDATES TO THE DESIGN THAT DID NOT AFFECT THE INTENDED USAGE OF THE DEVICE. THE COMPLAINT IS CONFIRMED FOR THE COMPLAINT CONDITION. THE METHOD OF USE HAS REDUCED THE HOLE DIAMETER AT THIS FEATURE CAUSING THE PROTECTION SLEEVE TO GET STUCK OR JAMMED WHEN INSERTED. ALL SUCH INSERTION HANDLE REMOVAL TECHNIQUES ARE INTENDED TO BE PERFORMED BY USING THE SLIDE HAMMER, HAMMER GUIDE, DRIVING CAP CONNECTED TO THE PROXIMAL SIDE OF THE INSERTION HANDLE. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A STANDARD INSERTION HANDLE BENT WHILE TESTING THE ANTIGRADE OPTION ON THE DEVICE. IT BENT AT THE ANTIGRADE SCREW HOLE. THE TROCAR WOULD NOT GO THROUGH THE HOLE IN THE INSERTION HANDLE DUE TO THE BENT METAL. THE DEVICE IS PART OF FIELD EQUIPMENT; THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323681 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 1603732

    Patients

    Seq Age Sex Outcome Treatment
    1