BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3232535 · Received July 18, 2013

    Report

    Report Number
    1719045-2013-01821
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED OCTOBER 30, 2012) INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.632.036, REVISION ¿J¿ AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), REVISION ¿R¿, COMPLETED NOVEMBER 5, 2012. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE RESULTS OF THE ADDITIONAL EVALUATION ARE AS FOLLOWS: OUR INVESTIGATION HAS SHOWN THAT THE FIRST TWO THREAD FLANKS AT THE FOREFRONT ARE BROKEN OFF AT THE RETAINING SLEEVE. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSES WHICH LEAD TO THIS OCCURRENCE. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN APRIL 2013 ACCORDING TO THE SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. HIGH LATERAL STRESS CAN LEAD TO SUCH A BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, THE TIP BROKE OFF. IT WAS ALSO REPORTED THE SURGEON IS A TRAINED MATRIX USER. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336120 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6972476

    Patients

    Seq Age Sex Outcome Treatment
    1