BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 3.5 F/DRILL BITS Ø2.8

    MDR report key: 2821906 · Received November 7, 2012

    Report

    Report Number
    8030965-2012-01200
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE RETURNED DRILL SLEEVE FOR CONFORMANCES TO 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. IT IS POSSIBLE THAT HIGH MECHANICAL FORCE DURING THE SURGERY MAY HAVE CAUSED THIS BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED; DEVICE WAS MANUFACTURED IN OCTOBER 2010 ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, THE TIP OF THE LCP DRILL SLEEVE BROKE. IT WAS REPORTED THE PARTS HAVE BEEN DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP DRILL SLEEVE 3.5 F/DRILL BITS Ø2.8 LCP DRILL SLEEVE HSB SYNTHES GMBH 2633777

    Patients

    Seq Age Sex Outcome Treatment
    1