BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD BRL 4-HOLE PLATE 135 DEG

    MDR report key: 7125129 · Received December 18, 2017

    Report

    Report Number
    3002806535-2017-01209
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    September 7, 2017
    Report Date
    May 22, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT RELATING TO THE REPORTED EVENT HAS BEEN RETURNED TO BIOMET (B)(4) LTD FOR EVALUATION AND INVESTIGATION. VISUAL CHECKS: ON RECEIVING THE ¿HIPLOC PLATE¿ AND ¿HIPLOC LAG SCREW¿ A VISUAL CHECK WAS PERFORMED WITH THE FOLLOWING OBSERVATIONS FOUND:- HIPLOC PLATE VARIOUS SCRATCHES AND MARKING FROM HANDLING AND ATTEMPTED IMPLANTATION. ETCHING IS CLEAR. HIPLOC LAG SCREW. VARIOUS SCRATCHES AND MARKING FROM HANDLING AND ATTEMPTED IMPLANTATION. ETCHING IS CLEAR. DOCUMENT REVIEW: A REVIEW OF THE MANUFACTURING HISTORY RECORDS FOR THE HIPLOC PLATE FROM THIS EVENT HAS NOT REPORTED ANY ABNORMALITIES OR DEVIATIONS. COMPLAINTS: 13 COMPLAINTS HAVE BEEN RECORDED FOR A SIMILAR ISSUE. 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. THE HIPLOC LAG SCREWS IN ALL RETURNED PRODUCT HAVE BEEN CONFIRMED AS CONFORMING TO PRE-DEFINED SPECIFICATION WHEN MANUFACTURED, AND REQUIRE NO FURTHER ACTION TO BE TAKEN. A SUPPLIER CORRECTIVE ACTION REPORT, SCAR-(B)(4), HAS BEEN RAISED ON SANATMETAL TO INVESTIGATE THEIR MANUFACTURING PROCESSES IN RELATION TO THE NON-CONFORMANCE. THE RISK ASSESSMENT RESIDUAL SCORE HAS INCREASED AND WILL BE CONSIDERED BY THE PRODUCT ENGINE MANAGEMENT TEAM AS PART OF A HEALTH HAZARD EVALUATION (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING A PROCEDURE, THE LAG SCREW WOULD NOT FIT THROUGH THE BARREL OF THE HIPLOC PLATE. ANOTHER NEW PLATE AND THE SAME LAGSCREW WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904149 STD BRL 4-HOLE PLATE 135 DEG DEVICE, FIXATION JDO BIOMET UK LTD. N/A 3918366

    Patients

    Seq Age Sex Outcome Treatment
    1