BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX

    MDR report key: 4792327 · Received May 22, 2015

    Report

    Report Number
    2530088-2015-10445
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 AIMING ARM WAS MANUFACTURED IN JUNE, 2005 AND IS OVER TEN YEARS OLD. THE AIMING ARM IS IN FAIRLY GOOD CONDITION SHOWING SOME MILD WEAR. 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. 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

    (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: MANUFACTURE DATE: JUNE 1, 2005. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND A MATERIAL RECORD REPORT (MRR) WAS FOUND ON PART NUMBER 03.010.048 / LOT 4963190 FOR CE NOT SHOWN. THE QUALITY ENGINEER ACCEPTED THE PARTS AS CONFORMS BECAUSE DOCUMENT CONTROL ORDER (DCO) TO ADD CE MARK WAS APPROVED ON APRIL 5, 2005. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE THE ISSUE IS VISUAL. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE 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 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 4 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335540 RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX GUIDE FZX SYNTHES BRANDYWINE 4963190

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention