BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR 2.4 SELF-TAP L18 TAN

    MDR report key: 2982616 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-00424
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 27, 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 USED FOR TREATMENT AND NOT DIAGNOSIS. RETRACT LOT NUMBER: NOT THE ACTUAL LOT NUMBER OF THE PRODUCT. FOUND AT DHR REVIEW. THE DHR REVIEW SHOWED THE NUMBER LISTED IS A STERILIZATION NUMBER AND NOT THE LOT NUMBER. THE DHR COULD NOT BE COMPLETED WITHOUT A LOT NUMBER. THE SCREW SHOWS A TOTALLY DEFORMED SCREW HEAD THREAD AND A DAMAGED SHAFT TREAD ON THIS SCREW. WE ASSUME THAT TOO MUCH FORCE GOT APPLIED TO THE SCREW HEAD. THE HEAD JAMMED WITH THE PLATE AND THE MATERIAL OF THE SCREW GOT WORN AWAY. NO PRODUCT FAULT COULD BE DETECTED. NO MANUFACTURING RELATED ISSUE WAS FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS EXPIRATION DATE: DATE PROVIDED FROM DHR REVIEW. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED. DATE OF DEVICE MANUFACTURE: DETERMINED DURING DHR REVIEW. LOT NUMBER IS AN EU LOT NUMBER.

    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.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PATIENT HAD A FRACTURE OF THE DISTAL RADIUS AND THE SURGEON PERFORMED A TCP OPERATION. THE DOCTOR INSERTED QUICK DRILL SLEEVE INTENDED FOR USE ONLY WITH THIS OPERATION INTO THE PLATE HOLE THROUGH THE GUIDING BLOCK LOCATED THE SECOND LINE AT THE DISTAL RADIUS SIDE. AFTER THE DRILLING OF THE DRILL SLEEVE, THE DOCTOR TRIED THE INSERTION WITH THE USE OF THE DRIVER WITHOUT TORQUE. AT LAST, WHEN THE DOCTOR WAS JUST ABOUT TO APPLY THE TORQUE, THE DRIVER PENETRATED AND THE DOCTOR COULD REMOVE THE SCREW. THE SCREW WAS REMOVED AND THEN THE PLATE WAS REMAINING. IT WAS REPORTED THE SURGEON BELIEVED THE VA LOCKSCR 2.4 SELF-TAP L18 TAN WAS DEFECT DEVICE, BECAUSE IT PENETRATED THE PLATE AT THE FIXED ANGLE MODE. THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88637 VA LOCKSCR 2.4 SELF-TAP L18 TAN LOCKING SCREW HWC SYNTHES MONUMENT 7057357

    Patients

    Seq Age Sex Outcome Treatment
    1