BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 BALL HEX DRVR FOR INSR HNDL

    MDR report key: 9879970 · Received March 25, 2020

    Report

    Report Number
    0001825034-2020-01277
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 18, 2020
    Report Date
    August 6, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D11; H2; H3; H4; H6 D11: 110003452, G7 STR INSRTR THREADED SHAFT, LOT NUMBER 061289 110010248, G7 OSSEOTI 4 HOLE SHELL 60MM G, LOT NUMBER 6665675 110003451, G7 STR MODULAR SHELL INSERTER, LOT NUMBER 253370 REPORTED EVENT WAS CONFIRMED WITH PRODUCT RETURN. VISUAL INSPECTION CONFIRMED THE HEX DRIVER TO BE FRACTURED. THE HANDLE SHOWS SIGNS OF DISCOLORATION. SCUFFS AND SURFACE SCRATCHES WERE OBSERVED ON THE SHAFT AND HANDLE CONSISTENT WITH A MULTIPLE USE INSTRUMENT. SEM TESTING SHOWED THE FRACTURE SURFACE IS MOSTLY FLAT WITH A FEW LIGHT ARTIFACTS IN A CIRCULAR PATTERN, CONSISTENT WITH A ROTATIONAL/TORSIONAL SHEAR FRACTURE. XRF ANALYSIS FOUND THE HEX DRIVER MATERIAL TO BE WITHIN SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, HOWEVER, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. 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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 110003452, G7 STR INSRTR THREADED SHAFT, LOT NUMBER UNKNOWN, 110010248, G7 OSSEOTI 4 HOLE SHELL 60MM G, LOT NUMBER 6665675, 110003451, G7 STR MODULAR SHELL INSERTER, LOT NUMBER 253370. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01274, 0001825034-2020-01275.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCRUB TECH UNKNOWINGLY CROSS THREADED THE G7 STRAIGHT INSERTER ONTO THE G7 CUP DURING INITIAL THA. UPON IMPACTING THE CUP INTO THE ACETABULUM, THE INSERTER BECAME COLD WELDED TO THE G7 CUP. INSERTER SCREWDRIVER BALL TIP BROKE OFF WHILE TRYING TO DISENGAGE INSERTER FROM CUP. CASE WAS CONVERTED TO THE CONTINUUM ACETABULAR SYSTEM WITH NO IMPACT TO THE SURGEON OR THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342696 G7 BALL HEX DRVR FOR INSR HNDL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LPH ZIMMER BIOMET, INC. N/A 061706

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE