BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L14 TAN

    MDR report key: 3003776 · Received March 14, 2013

    Report

    Report Number
    1719045-2013-00536
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 16, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K102694
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES. THE INVESTIGATION HAS SHOWN THAT THE SCREW HAS WORN OUT STAR DRIVE; A WORN OUT HEAD THREAD AND THE SHAFT THREAD IS SLIGHTLY DAMAGED TOO. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. WE ASSUME THAT THE DAMAGE ON THE SCREW RESULTED OUT OF THE CONTACT WITH THE SCREWDRIVER AND PLATE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: TIGHTENING TORQUE DID NOT WORK. ON (B)(6) 2013, A (B)(6) FEMALE PATIENT UNDERWENT SURGERY TO REPAIR A FRACTURE OF THE LEFT DISTAL RADIUS. DURING THE PROCEDURE THE DISTAL LOCKING SCREW PENETRATED THE FRACTURED DISTAL RADIUS. THE PLATE WAS ATTACHED WITH A GUIDING BLOCK TO THE KIRSCHNER WIRE AND ELLIPSOIDAL HOLE BY USE OF CORTSCR DIAMETER 2.7. THE SURGEON MADE A SKIN INCISION FOLLOWED BY MANIPULATION AND TEMPORARILY FIXATION OF THE KIRSCHNER WIRE ON THE FRACTURE OF THE LEFT DISTAL RADIUS. FOR THE MOST DISTAL POSITION, THE SURGEON INSERTED THE SCREW WITH THE FIXATION MODE. THE SCREWS WERE INSERTED RADIAL-WARD BUT THE SCREW TIGHTENING TORQUE OF THE DRIVER DID NOT WORK. AS A RESULT, THE SURGEON COULD NOT SEE AN IMAGE IN THE OPERATIVE FIELD. AFTER THE BLOCK ATTACHED TO THE PLATE WAS REMOVED, THE DOCTOR NOTED THE PENETRATION BY THE SCREW WITH NO TORQUE. AFTER THE RECOVERY OF THE REMOVED SCREW, THE VA LCP 2 COLUMN REMAINED INSIDE THE PATIENTS ARM AND WILL BE RECOVERED AFTER THE REMOVAL FOR THE FOLLOWING REASONS: THE FIXATION OF THE PLATE WAS COMPLETED AND PER THE DOCTOR THERE WAS NO PROBLEM WITHOUT THE SCREW. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107523 VA LOCKSCR Ø2.4 SELF-TAP L14 TAN HWC SYNTHES MONUMENT 7666661

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR