BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5 LCP OLECRANON PLATE 4 HOLES/LEFT/112

    MDR report key: 13471469 · Received February 7, 2022

    Report

    Report Number
    2939274-2022-00379
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982160713
    PMA / PMN Number
    K000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: THE PLATE HAD BEEN DEFORMED AND SCRATCHED. A DEFINITIVE ROOT CAUSE OF THIS ISSUE WAS NOT DETERMINED DURING INVESTIGATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT:PART: 236.505 LOT: 1913678 MANUFACTURING SITE: (B)(4). SUPPLIER: N/A RELEASE TO WAREHOUSE DATE: 07 JUN 2008 EXPIRATION DATE: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLATE WAS MODIFIED AND REPACKAGED. THE HOLE HAD BEEN CUT AND SHAVED THEN POLISHED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5 LCP OLECRANON PLATE 4 HOLES/LEFT/112 THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595570 3.5 LCP OLECRANON PLATE 4 HOLES/LEFT/112 APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 236.505 10886982160713

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown