BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STD BRL LAG SCRW 12.5X115MM

    MDR report key: 7876107 · Received September 14, 2018

    Report

    Report Number
    3002806535-2018-01082
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    July 1, 2018
    Report Date
    December 12, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HSB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    ZFA-2018-00210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT RELATING TO THE REPORTED EVENT HAS BEEN RETURNED TO (B)(4) FOR EVALUATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS FOR THE HIPLOC PLATE FROM THIS EVENT HAS NOT REPORTED ANY ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE COMPLAINT DATABASE FOUND 17 SIMILAR COMPLAINTS REPORTED FOR THIS ITEM CODE. THE RETURNED HIPLOC PLATES HAVE BEEN CONFIRMED AS NON-CONFORMING. THE INTERNAL BARREL ON THE HIPLOC PLATE HAS BEEN CONFIRMED AS UNDERSIZED THROUGH DIMENSIONAL CHECKS. A SUPPLIER CORRECTIVE ACTION REPORT, (B)(4), HAS BEEN RAISED ON SANATMETAL TO INVESTIGATE THEIR MANUFACTURING PROCESSES IN RELATION TO THE NON-CONFORMANCE. A CAPA (B)(4) HAS BEEN RAISED TO INVESTIGATE RECEIPT AND RELEASE OF PRODUCT. PRODUCT HOLD HAS BEEN INITIATED: (B)(4). A HHE HAS BEEN COMPLETED: (B)(4). A FIELD ACTION DETERMINATION HAS BEEN COMPLETED: (B)(4).

    Description of Event or Problem · 0

    HIPLOC PLATE AND SCREW COULD NOT BE ASSEMBLED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - STD BRL 4-HOLE PLATE 135 DEG , ITEM 2110-135-004, LOT 6192491. 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 REPORTS: 3002806535-2018-01083.

    Description of Event or Problem · 1

    THE HIPLOC PLATE HOLE IS TOO SMALL FOR THE SCREW TO GO THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720298 STD BRL LAG SCRW 12.5X115MM HSB BIOMET UK LTD. 2017010792

    Patients

    Seq Age Sex Outcome Treatment
    1