BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3060970 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-01067
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 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 IS USED FOR TREATMENT, NOT DIAGNOSIS MAGNUM MANUFACTURING CENTER MANUFACTURED THE RETAINING SLEEVE ¿ LONG FOR MATRIX, P/N 03.632.036, LOT 6583190. DUE TO AN UNKNOWN CAUSE, PART OF THE THREADED TIP BROKE OFF. THE PARTS CONFORMED TO ALL DIMENSIONAL AND MATERIAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE PERTINENT MATERIAL AND HARDNESS SPECIFICATIONS HAVE BEEN CONFIRMED. THE THREADS AND INNER DIAMETER OF THE INNER SLEEVE WERE CONFIRMED TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MAGNUM MANUFACTURING CENTER MANUFACTURED THE HOLDING SLEEVE ¿ LONG FOR MATRIX, PART 03.632.036, AND LOT NUMBER 6583190. THE SUPPLIER CERTIFICATE OF COMPLIANCE, DATED MAY 17, 2011, INDICATES THE PARTS WERE MANUFACTURED TO PART 03.632.036, REVISION G AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, TABULATED INCOMING FINAL INSPECTION SHEET. THERE WERE NO NON CONFORMITIES OR OTHER COMPLAINT RELATED ISSUES ASSOCIATED WITH THIS COMPLAINT. THE INVESTIGATION SHOWS A BREAKAGE OF A PART OF THE FIRST THREAD AT THE THREAD TIP. WE ASSUME THAT NOT ENOUGH ATTRACTING COULD INTO THE PRIME LOCK THREAD OF THE BONE SCREW BE THE POSSIBLE CAUSE OF THIS DAMAGE. WITH THE LOCKING RETAINING SLEEVE, 03.616.043, SYNTHES IS PROVIDING AN ALTERNATIVE INSTRUMENT, WHICH CAN BE HELD DURING THE INSERTING PROCEDURE. THE CONDUCTED INVESTIGATIONS OF THE MANUFACTURING AND MATERIAL DOCUMENTS SHOW NO DEVIATION ACCORDING OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 FOR THIS LOT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4)REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE THREADS OF A RETAINING SLEEVE WERE BROKEN. IT IS REPORTED THAT THE THREAD BROKE AT THE BASE OF THE RETAINING SLEEVE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162898 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6583190

    Patients

    Seq Age Sex Outcome Treatment
    1