BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS INSERTION HANDLE

    MDR report key: 4792340 · Received May 22, 2015

    Report

    Report Number
    3003875359-2015-10232
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: SEPTEMBER 29, 2006. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE RECON LOCKING AIMING ARM (PART 03.010.048 / LOT 4963190), PERCUTANEOUS INSERTION HANDLE (PART 03.010.046 / LOT 1448915), 12.0MM/8.0MM PROTECTION SLEEVE (PART 03.010.063 / LOT 1802328), 8.0MM/4.2MM DRILL SLEEVE (PART 03.010.065 / LOT 1753339), AND THE 4.2MM TROCAR (PART 03.010.070 / LOT 5611943) WAS LIKELY CAUSED BY A SOFT TISSUE OBSTRUCTION OR INSUFFICIENT TIGHTENING OF THE AIMING DEVICES; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. A REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE RECON LOCKING AIMING ARM, PERCUTANEOUS INSERTION HANDLE, 12.0MM/8.0MM PROTECTION SLEEVE, 8.0MM/4.2MM DRILL SLEEVE, AND THE 4.2MM TROCAR ARE INSTRUMENTS ROUTINELY USED IN THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL SYSTEM. THE DEVICES WERE RETURNED AND REPORTED TO HAVE CONTRIBUTED TO THE AIMING ARM NOT LINING UP FOR PROXIMAL LOCKING WITH THE NAIL. THIS CONDITION IS UNCONFIRMED; WHEN TESTED WITH A TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL (PART 04.003.245 / LOT 7533617) AND A CANNULATED CONNECTING SCREW (PART 03.010.146 / LOT U197773), THE DEVICES ALIGN PROPERLY WITH THE NAIL¿S PROXIMAL LOCKING HOLES. IT IS LIKELY THAT SOFT TISSUE OBSTRUCTED THE PATH OF THE LOCKING SCREWS OR THAT THE AIMING DEVICES WERE NOT FASTENED TOGETHER ENTIRELY LEADING TO THIS COMPLAINT CONDITION. THE INSERTION HANDLE WAS MANUFACTURED IN SEPTEMBER, 2006 AND IS OVER EIGHT YEARS OLD. THE INSERTION HANDLE IS IN GOOD CONDITION EXCEPT FOR SOME HAMMER MARKS ON THE UNDERSIDE OF THE DEVICE. THE ASSOCIATED DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION. THE COMPLAINT CONDITION FOR THIS DEVICE CANNOT BE REPLICATED. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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

    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 AN AIMING ARM WOULD NOT LINE UP WITH A FEMORAL NAIL AND THIS PREVENTED PROXIMAL LOCKING. THERE WAS A DELAY BETWEEN 20-30 MINUTES, WHILE THE SURGEON WAS TRYING BOTH THE STATIC AND DYNAMIC HOLES. THERE WAS NO REPORTED HARM TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE FRACTURE APPEARED STABLE, SO PATIENT OUTCOME LOOKS TO BE POSITIVE. THIS REPORT IS 5 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335608 PERCUTANEOUS INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 1448915

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention