BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD BRL 4-HOLE PLATE 135 DEG

    MDR report key: 7532622 · Received May 22, 2018

    Report

    Report Number
    3002806535-2018-00838
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 25, 2018
    Report Date
    October 4, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT RELATING TO THE REPORTED EVENT HAS BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION. THE RETURNED HIPLOC PLATES HAVE BEEN CONFIRMED AS NON-CONFORMING. THE INTERNAL BARREL ON THE HIPLOC PLATE HAS BEEN CONFIRMED AS UNDERSIZE THROUGH DIMENSIONAL CHECKS. A REVIEW OF THE MANUFACTURING HISTORY RECORDS FOR THE HIPLOC PLATE FROM THIS EVENT HAS NOT REPORTED ANY ABNORMALITIES OR DEVIATIONS. 13 COMPLAINTS HAVE BEEN RECORDED FOR A SIMILAR ISSUE. A SUPPLIER CORRECTIVE ACTION REPORT, SCAR- 01951, HAS BEEN RAISED ON SANATMETAL TO INVESTIGATE THEIR MANUFACTURING PROCESSES IN RELATION TO THE NON-CONFORMANCE. A CAPA, CA-04598 HAS BEEN RAISED TO INVESTIGATE RECEIPT AND RELEASE OF PRODUCT. PRODUCT HOLD HAS BEEN INITIATED: PH-2018-00225-EMEA A HHE HAS BEEN COMPLETED: HHE-2018000210 . A FIELD ACTION DETERMINATION HAS BEEN COMPLETED: ZFA-2018-00210

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    HIPLOC PLATE AND SCREW IS NOT IMPLANTED AS THE SURGEON WAS NOT ABLE TO DISASSEMBLE THE SCREW FROM THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377472 STD BRL 4-HOLE PLATE 135 DEG HRY BIOMET UK LTD. N/A 6229927

    Patients

    Seq Age Sex Outcome Treatment
    1