BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD BRL 4-HOLE PLATE 135 DEG

    MDR report key: 7951193 · Received October 10, 2018

    Report

    Report Number
    3002806535-2018-01126
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    June 11, 2018
    Report Date
    March 6, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    3002806535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2018-001127-1. 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 WERE PREVIOUSLY RECORDED FOR THIS REPORTED ISSUE. A SUPPLIER CORRECTIVE ACTION REPORT, SCAR- 01951, HAS BEEN RAISED ON SANATMETAL TO INVESTIGATE THEIR MANUFACTURING PROCESSES IN RELATION TO THE NON-CONFORMANCE. PRODUCT HOLD HAS BEEN INITIATED: PH-2018-00225-EMEA A CORRECTIVE AND PREVENTATIVE ACTION, CA-04598 HAS BEEN RAISED TO INVESTIGATE RECEIPT AND RELEASE OF PRODUCT. A HEALTH HAZARD EVALUATION HAS BEEN COMPLETED (HHE-2018-00210), RESULTING IN A FIELD ACTION DETERMINATION: ZFA-2018-00210.

    Description of Event or Problem · 0

    HIPLOC PLATE AND SCREW DOES NOT ASSEMBLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- UNKNOWN SCREW. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2018-001127.

    Description of Event or Problem · 1

    HIPLOC PLATE AND SCREW DOES DID NOT ASSEMBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792897 STD BRL 4-HOLE PLATE 135 DEG JDO BIOMET UK LTD. 6187959

    Patients

    Seq Age Sex Outcome Treatment
    1