BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRO FEM CONNECTING BOLT

    MDR report key: 10600399 · Received September 29, 2020

    Report

    Report Number
    0001825034-2020-03654
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    August 29, 2020
    Report Date
    February 10, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    UDI-DI
    00887868094309
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 14-444236 FEM NAIL RETRO 10.5MM X 360MM 210200; 14-442019 RETROGRADE FEM NL DRIVER UNKNOWN. FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03653.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY WHEN THE PHYSICIAN TRIED TO PUT A RETROGRADE NAIL, THE DRIVER NOSE PULLED OUT OF THE NAIL. THE SURGEON HAD TO EXTRACT THE NAIL AS THE THREAD OF THE BOLT WAS SHORT AND HENCE RESULTED IN A SURGICAL DELAY OF TWO HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064765 RETRO FEM CONNECTING BOLT SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. 14-442021 UNKNOWN 00887868094309

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE NARRATIVE IN H10