BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNEC F/INSERTION HANDLE F/PFNA

    MDR report key: 3962240 · Received July 28, 2014

    Report

    Report Number
    9612488-2014-10304
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM 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: A MANUFACTURING EVALUATION WAS COMPLETED: THE INVESTIGATION HAS SHOWN THAT THE THREADED TIP IS BROKEN OFF AS COMPLAINED. THERE ARE MULTIPLE HITTING MARKS VISIBLE ON THE ROTARY HANDLE AS WELL AS ON THE SHAFT, POINTING TO THE FACT THAT THE INSTRUMENT WAS NOT USED ACCORDING TO THE SURGICAL TECHNIQUE. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS CONNECTOR WAS MANUFACTURED IN SEPTEMBER 2012 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES WERE FOUND THAT WOULD HAVE LED TO THIS COMPLAINT. THE FRACTURE SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. BASED ON THESE FINDINGS WE ASSUME THAT A MECHANICAL OVERLOADING SITUATION CAUSED THE BREAKAGE. NO PRODUCT FAULT WAS DETECTED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE TIP SIDE (BLACK PART) OF CONNECTOR FOR INSERTION HANDLE WAS BROKEN WHEN INSERTING INTO THE INSERTION HANDLE, IT WAS REPORTED TO BE INSERTED CORRECTLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439569 CONNEC F/INSERTION HANDLE F/PFNA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES BETTLACH 7995424

    Patients

    Seq Age Sex Outcome Treatment
    1