BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 5463493 · Received February 26, 2016

    Report

    Report Number
    3003875359-2016-10126
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Report Date
    February 8, 2016
    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

    ADDITIONAL NARRATIVE: AN PD INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE 03.010.045 STANDARD INSERTION HANDLE IS AN INSTRUMENT ROUTINELY USED DURING THE INSERTION OF FEMORAL AND TIBIAL NAILS INCLUDING IN THE TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM AND THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL SYSTEM AMONG OTHERS. IT WAS REPORTED THAT DURING FIELD INVENTORY A RECON LOCKING AIMING ARM (03.010.048 LOT 5757773 MFG 08APR2008) WOULD NOT ALIGN PROPERLY WITH A STANDARD INSERTION HANDLE (03.010.045 LOT 1992611 MFG 06NOV2008). THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE RETURNED INSTRUMENTS WERE EXAMINED WERE ABLE TO BE ASSEMBLED AS INTENDED FORMING A TIGHT, RIGID ASSEMBLY. AS THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED, THE COMPLAINT IS UNCONFIRMED. THE CALCULATED OCCURRENCE RATE IS ACCEPTABLE UNDER THE SYSTEM RISK ASSESSMENT. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 THAT DURING A ROUTINE INSTRUMENT INSPECTION, IT WAS DISCOVERED THAT THE RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX AND THE STANDARD INSERTION HANDLE WERE NOT ALIGNING PROPERLY. THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121245 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 1992611

    Patients

    Seq Age Sex Outcome Treatment
    1