BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE LOCK SCREW 4.75X25MM

    MDR report key: 7637787 · Received June 26, 2018

    Report

    Report Number
    0001825034-2018-04273
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    October 13, 2015
    Report Date
    June 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWJ
    PMA / PMN Number
    PK080426
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 180322, MAESTRO TC CAPITATESTEM 6X18MM, 013330; 180363, MAESTRO TC CARPALHD 7X15MM STD, 818610; 180482, MAESTRO RADIAL STEM 7.5X60MM, 738690; 180151, MAESTRO RAD W/BRG 7X15 7.5 RT, 217150; 180351, VARIABLE LOCK SCREW 4.75X20MM, 551340; 180304, MAESTRO TC CARPALPT 9X37 9 AUG, 837790; 180355, VARIABLE LOCK SCREW 4.75X40MM, 551300; 180357, VARIABLE LOCK SCREW 4.75X50MM, 872250. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04268; 0001825034 - 2018 - 04269; 0001825034 - 2018 - 04270; 0001825034 - 2018 - 04271; 0001825034 - 2018 - 04272; 0001825034 - 2018 - 04266; 0001825034 - 2018 - 04274; 0001825034 - 2018 - 04275. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S ORIGINAL WRIST REPLACEMENT HAD TO BE REMOVED DUE TO INFECTION AND CAUSED THE CARPALS TO BE DAMAGED ENOUGH THAT A STANDARD PLATE WOULD NOT WORK. SUBSEQUENTLY, THE SURGEON REQUESTED A PATIENT MATCHED CARPAL PLATE TO GET A NEW WRIST REPLACEMENT. IN ADDITION, THE SURGEON BELIEVES THE RISK OF INFECTION COMING BACK TO THE POINTER FINGER REQUIRES CUSTOM SCREW PLACEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480601 VARIABLE LOCK SCREW 4.75X25MM PROSTHESIS, WRIST JWJ ZIMMER BIOMET, INC. N/A 551330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R