BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 5 F/DRILL BIT Ø4.3

    MDR report key: 2991030 · Received March 6, 2013

    Report

    Report Number
    8030965-2013-00779
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION ON (B)(4) 2013. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE RETURNED DRILL SLEEVE WAS CHECKED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORDS WERE REVIEWED. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. WE SUPPOSE THAT HIGH MECHANICAL FORCE DURING THE SURGERY MAY HAVE CAUSED THIS BREAKAGE. NOTE THAT THE LOT IN QUESTION WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: A LCP DRILL SLEEVE WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94941 LCP DRILL SLEEVE 5 F/DRILL BIT Ø4.3 FZX SYNTHES GMBH 7724598

    Patients

    Seq Age Sex Outcome Treatment
    1