BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DVR CROSSLOCK 1.7 MM SQUARE DRIVER

    MDR report key: 7111994 · Received December 13, 2017

    Report

    Report Number
    0001825034-2017-10907
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 8, 2017
    Report Date
    May 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWR
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. WHEN SUBJECTED TO SCANNING ELECTRON MICROSCOPY (SEM ANALYSIS), THE DRIVER SHOWED INDICATIONS OF OVERLOAD OF FRACTURE BY EXHIBITING DUCTILE DIMPLES. THE ORIENTATION CHANGES OF THE DUCTILE DIMPLES ON THE FRACTURE SURFACE SUGGESTED A TORSION OVERLOAD. WHEN SUBJECTED TO ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (EDS ANALYSIS)THE DEVICE'S MATERIAL COMPOSITION WAS FOUND TO BE CONSISTENT WITH PRODUCT SPECIFICATIONS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS: 131821051, DVR LOCK NARROW L ST, 237820; 131827114, LOCK SCREW SQ 2.7MM 14MM STE, 510580; 131827116, LOCK SCREW SQ 2.7MM 16MM STE, 815500; 131827118, LOCK SCREW SQ 2.7MM 18MM STE, 822700; 131827118, LOCK SCREW SQ 2.7MM 18MM STE, 872100; 131827120, LOCK SCREW SQ 2.7MM 20MM STE, 870510.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL VOLAR RADIUS PLATING PROCEDURE, THE TIP OF THE DRIVER FRACTURED OFF INSIDE OF A SCREW HEAD. THE FRACTURED PORTION OF THE DRIVER WAS UNABLE TO BE RETRIEVED FROM THE SCREW HEAD AND REMAINS IN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893353 DVR CROSSLOCK 1.7 MM SQUARE DRIVER DRIVER, PROSTHESIS HWR ZIMMER BIOMET, INC. N/A CA5D708

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability