BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW DRILL 3.2 MM DIAMETER

    MDR report key: 10453852 · Received August 26, 2020

    Report

    Report Number
    0001822565-2020-03031
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    August 7, 2020
    Report Date
    November 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G4, G7, H1, H2, H3, H6, H10 THIS COMPLAINT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND SIGNS OF REPEATED USE (NICKED OR GOUGED) AND IS FRACTURED. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED BONE SCREW DRILL SAMPLE SHOWED THAT IT SUSPECTED TO HAVE FRACTURED TO DUE TO REVERSE BENDING OVERLOAD. XRF ANALYSIS OF THE BONE SCREW DRILL FRACTURE SURFACE CONFIRMED THE MATERIAL. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND RETAINED METALLIC DRILL BIT IN THE MEDIAL TIBIAL METAPHYSIS SUBCORTICAL REGION. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00-5980-037-01 J6716264 NGK STEM TIB PLATES PRE S#3, 00-5764-014-52 64274677 LPS-FLEX GSF OPT FEM SZ D RT, 00-5972-065-26 64257221 NGK ALL-POLY PATELLA,26MM, 00-5962-030-10 63887539 LPS-FLEX FIX PROLG AS CD 3-4MM, 00-5980-037-01 J6716264 NGK STEM TIB PLATES PRE S#3, 00-5764-014-51 64585585 LPS-FLEX GSF OPT FEM SZ D LEFT, 00-5972-065-26 64545028 NGK ALL-POLY PATELLA,26MM, 00-5962-030-10 64704433 LPS-FLEX FIX PROLG AS CD 3-4MM. REPORT SOURCE: FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE FRACTURED END OF THE PRODUCT THAT IS NOT RETAINED BY PATIENT 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 THE DRILL BIT FRACTURED DURING THE INITIAL IMPLANT PROCEDURE AND THE FOREIGN BODY WAS RETAINED BY THE PATIENT AS THE SURGEON FELT REMOVAL OF THE FOREIGN BODY WOULD RISK DISRUPTING TOO MUCH CANCELLOUS BONE IN A POTENTIALLY EXTENSIVE ATTEMPT TO REMOVE THE DRILL BIT FRAGMENT. ATTEMPTS HAVE BEEN MADE HOWEVER NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919660 BONE SCREW DRILL 3.2 MM DIAMETER INSTRUMENT HWT ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R