BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MMX30MM RNGLC+ ACET DRL BIT

    MDR report key: 16247146 · Received January 26, 2023

    Report

    Report Number
    0001825034-2023-00166
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 3, 2023
    Report Date
    April 18, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    UDI-DI
    00887868478703
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED: LOT# 65730675 - VISUAL INSPECTION FOUND THE TIP OF THE DRILL BIT TO BE BENT. THE BIT IS OTHERWISE IN DECENT CONDITION WITH LITTLE TO NO SIGNS OF WEAR. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 31-323230 3.2MMX30MM RNGLC+ ACET DRL BIT 65756298. 20-8060-001-00 ROSA QUICK CONNECT INTERFACE. 20-8060-002-00 ROSA QUICK CONNECT SLEEVE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00167. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DRILL BITS BROKE UNDER NORMAL USE AND NO EXTREME ANGLES. CUP WAS IMPACTED INTO THE PATIENT. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793718 3.2MMX30MM RNGLC+ ACET DRL BIT HIP, INSTRUMENTS HTW ZIMMER BIOMET, INC. N/A 65730675 00887868478703

    Patients

    Seq Age Sex Outcome Treatment
    1 Female SEE H10 NARRATIVE