BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT INSERTION SLEEVE Ø12 L271 F/PERC

    MDR report key: 3193272 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04036
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT ALL THE INSTRUMENTS HAD A SLIGHT DEFORMATION ON THE TOP SIDE. THIS DAMAGE HAS THE EFFECT THAT THE BORE IS NOT ROUND ANYMORE. THEREFORE THE SLEEVES CANNOT FIT IN EACH OTHER OR ARE HARD TO MERGE. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WERE FOUND.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PART WAS DAMAGED AND NOT WORKING AT ALL. THE WINGS ON THE IN-SPACE IMPLANT COULD NOT BE DEPLOYED AND EXTENDED. THE SAME HAPPENED AFTER CHANGING THE IMPLANT. THE IMPLANTS HAD TO BE REMOVED AND WASTED. DURING REMOVAL OF THE DISTRACTION SLEEVES THEY GOT STUCK AND EVERYTHING HAS TO BE TAKEN OUT AND THE SLEEVES HAVE TO BE HAMMERED ON A TABLE TO TAKE APART. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292577 IMPLANT INSERTION SLEEVE Ø12 L271 F/PERC HSZ SYNTHES GMBH 1685357

    Patients

    Seq Age Sex Outcome Treatment
    1