BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3183176 · Received June 21, 2013

    Report

    Report Number
    1719045-2013-01596
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2012
    Report Date
    May 29, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. THE ADDITIONAL EVALUATION REVEALED THAT THE THREADS TIP IS INDEED BROKEN APART. UNFORTUNATELY WE ARE NOT ABLE TO REPRODUCE THIS DAMAGE IN RETROSPECTIVE, AS WE HAVE NO DETAILED INFORMATION. WE CAN ONLY ASSUME THAT THE BREAKAGE HAS BEEN CAUSED BY TOO MUCH MECHANICAL STRESS / HANDLING. OF COURSE, IT IS A DELICATE DESIGN WITH THE THREAD BEING QUITE THIN-WALLED; THEREFORE IT IS IMPORTANT TO FOLLOW THE CORRESPONDING OP-TECHNIQUE. THE REVIEW OF THE MATERIAL AND MANUFACTURING DOCUMENTS DID NOT SHOW ANY DISCREPANCIES TO THE SPECIFICATIONS ACTUALLY, THE ARTICLE CORRESPONDS TO THE NEW VERSION. NO PRODUCT FAULT COULD BE DETECTED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.THE DEVICE HISTORY RECORD REVIEW STATES THE SUPPLIERS CERTIFICATE OF COMPLIANCE INDICATES THE PARTS WERE MANUFACTURED TO AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PART IS BROKEN AWAY AT THE THREAD OF THE HOLDING SLEEVE. HOLDING SLEEVE CANNOT BE CONNECTED WITH THE SCREW HEAD ANYMORE AND IT SPINS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283582 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6489807

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR