BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PROXTIBPL 3.5 LAT LE SHAFT 4HO L81 T

    MDR report key: 3173944 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03419
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    February 22, 2011
    Report Date
    May 20, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION HAS SHOWN THAT THE LOCKING HEAD OF THE SCREW IS STRONGLY BLOCKED INSIDE THE THREADED HOLE OF THE PLATE. THE THREADS ARE COMPLETE FRETTED TOGETHER. UNFORTUNATELY, WE ARE NOT ABLE TO ELABORATE THE EXACT REASON WHICH HAS LEAD TO THIS PHENOMENON. EITHER, EXTREME MECHANICAL FORCE WAS APPLIED DURING THE REMOVAL SURGERY WHICH MAY ULTIMATELY HAVE LED TO THE SCREW BREAKAGE. IT IS ALSO PROPOSED THAT TOO MUCH APPLIED MECHANICAL FORCE WAS APPLIED WHILE TIGHTENING OR ANOTHER POSSIBLE REASON COULD BE AN INSTABLE FRACTURE WHICH LED TO MICRO MOVEMENT OF THE IMPLANTS WHICH CAN CAUSE SUCH FRETTING AS WELL. NO PRODUCT FAULT COULD BE DETECTED. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WHILE THREE POSSIBLE REASONS ARE PROPOSED, WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING THE EXACT CAUSE OF FAILURE AND THE COMPLAINT CONDITION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REMOVAL OPERATION, ONE SCREW OF PROXIMAL 4 SCREWS WAS FOUND BROKEN UNDER THE SCREW HEAD. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273713 LCP PROXTIBPL 3.5 LAT LE SHAFT 4HO L81 T HWC SYNTHES GMBH 3332308

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR