BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 2883286 · Received December 21, 2012

    Report

    Report Number
    1719045-2012-01430
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K103242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE SCREW RECEIVED IS CONTAINED IN A PROPERLY SEALED SYNTHES PACKAGE WITH NO EVIDENCE OF TEARS OR OPENINGS OF ANY TYPE. THE PRINTED LABEL INDICATES THAT IT CONTAINS A 04.210.118, LOT NUMBER 6984291. UPON EXAMINATION THROUGH THE PACKAGING WITH A 10X MAGNIFIER, CHIP WRAP WAS FOUND AT THE NECK OF THE SCREW. THE PACKAGE WAS OPENED TO ALLOW FURTHER EXAMINATION. NO OTHER BURRS/CHIPS WERE NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: SCREWS IN UNOPENED PACKAGES WERE TAKEN FROM STOCK AND IT WAS NOTICED THERE WERE VISIBLE CHIPS ON ALL SCREW HEADS. THERE WAS NO PATIENT INVOLVEMENT. THIS IS 3 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN VA LOCKSCREW HWC SYNTHES MONUMENT 6984291

    Patients

    Seq Age Sex Outcome Treatment
    1