BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX

    MDR report key: 6112195 · Received November 18, 2016

    Report

    Report Number
    3003875359-2016-10603
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Report Date
    October 27, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 03.010.048 WITH LOT NUMBER 9200420 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS MAY 05, 2015. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 03.010.048, LOT # 9200420. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: APRIL 30, 2015. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE ARM WAS BROKEN OFF. THE REPAIR TECHNICIAN REPORTED THE ARM WAS BROKEN AND MISSING A LOCKING PIN. MISSING PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: AFTER SERVICE AND REPAIR THE DEVICE WAS FORWARDED TO CUSTOMER QUALITY FOR EVALUATION. PER THE TECHNIQUE GUIDE, THE RETURNED AIMING ARM IS USED FOR TARGETED LOCKING IN THE LATERAL ENTRY FEMORAL RECON NAILING SYSTEM. THE COMPLAINT CONDITION IS CONFIRMED AS THE AIMING ARM WAS RECEIVED WITH A LOCKING CAM KNOB DISASSEMBLED FROM THE MAIN BODY OF THE DEVICE AND WITH AN INTERNAL RETURN SPRING AND A DOWEL PIN MISSING. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, DRAWING REVIEW, COMPLAINT HISTORY REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND IS IN WORKING CONDITION. THUS, THE COMPLAINT CONDITION IS CONFIRMED. HOWEVER, IT DIFFERS SLIGHTLY FROM THE REPORTED CONDITION AS NO BREAKS WERE OBSERVED WITH THE RETURNED COMPONENTS. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE COMPONENTS ARE ALREADY MISSING. A REVIEW OF THE CURRENT DESIGN DRAWING/MANUFACTURED REVISION FOR THE TOP LEVEL ASSEMBLY, THE LOCKING CAM, THE LOCKING CAM KNOB, AND THE DOWEL PIN WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CONDITION IS CONSISTENT WITH WEAR AND THERMAL CYCLING FROM EXTENSIVE USE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE AND REPAIR THAT THE ARM OF THE RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EXPERT SYSTEM IS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS FOUND DAMAGED BY THE STERILE PROCESSING DEPARTMENT; IT WAS CONFIRMED THE DEVICE WAS NOT FOUND BROKEN DURING A SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763959 RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX GUIDE FZX SYNTHES HAGENDORF 9200420

    Patients

    Seq Age Sex Outcome Treatment
    1