BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 5523197 · Received March 24, 2016

    Report

    Report Number
    3003875359-2016-10200
    Event Type
    Injury
    Date Received
    March 24, 2016
    Date of Event
    March 6, 2016
    Report Date
    March 6, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PRODUCT INVESTIGATION SUMMARY: A RECON LOCKING AIMING ARM (PART 03.010.048 / LOT 5786347) AND A STANDARD INSERTION HANDLE (PART 03.010.045 / LOT 8935138) WERE RETURNED FOR EVALUATION. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED AS THE DEVICES SHOWED NO IDENTIFIABLE DEFECTS OR DEFICIENCIES WHICH COULD POTENTIALLY CONTRIBUTE TO THE COMPLAINT CONDITION. THE 9MM LATERAL ENTRY FEMORAL RECON NAIL WAS IMPLANTED AND WILL NOT BE RETURNED. AS SUCH, NO EVALUATION INCLUDING COULD BE COMPLETED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RECON LOCKING AIMING ARM IS EXCLUSIVELY UTILIZED IN THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL SYSTEM AND IS ATTACHED TO THE STANDARD INSERTION HANDLE FOR PROXIMAL LOCKING. THE RETURNED DEVICES WERE EXAMINED UPON ARRIVAL AND NO DEFECTS OR DEFICIENCIES, ASIDE FROM MINOR WEAR, WERE NOTED WHICH WOULD CONTRIBUTE TO THE COMPLAINT CONDITION OF MISALIGNMENT. THE AIMING ARM WAS ABLE TO ATTACH TO THE HANDLE MAKING FOR A STRONG AND RIGID CONSTRUCT. THE TECHNIQUE GUIDE NOTES THAT SURGEON¿S SHOULD NOT EXERT FORCES ON THE AIMING ARM, PROTECTION SLEEVES, OR DRILL SLEEVES. THESE FORCES MAY PREVENT ACCURATE TARGETING THROUGH THE PROXIMAL LOCKING HOLES. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENTS WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE): INSERTION HANDLE AND AIMING ARM. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USES OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENTS' LOT NUMBERS WITH NO COMPLAINT-RELATED ISSUES IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE FAILURE MODE OF MISALIGNMENT IS CONTRIBUTABLE TO ANY NUMBER OF FACTORS INCLUDING THE APPLICATION OF FORCES ON THE INSERTION CONSTRUCT. DEVICE 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

    PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: 16-JUNE-2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2016 IN ORDER TO TREAT A MIDSHAFT FEMUR FRACTURE RESULTING FROM A VEHICLE ACCIDENT. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE AIMING ARM MISSED THE SCREW HOLES PROXIMALLY. AN ATTEMPT WAS MADE LATERALLY TO MEDIAL STATIC THE SCREW HOLE, BUT THE DRILL BIT MISSED THE SCREW. THE SCREW WAS REMOVED AND AN ALTERNATE SCREW (120-DEGREE) WAS INSERTED, BUT THE SAME RESULT WAS ACHIEVED. THE SURGEON WAS UNABLE TO LOCK THE NAIL PROXIMALLY, BUT WAS SUCCESSFUL IN ACHIEVING DISTAL LOCKING. THE PROCEDURE WAS PROLONGED BY THIRTY (30) MINUTES DUE TO THE INTRA-OPERATIVE ALIGNMENT ISSUE. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180849 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8935138

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention