BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.9MM TOGGLELOC WITH ZIPLOOP WITH NEEDLES, #2 MAXBRAID

    MDR report key: 6024639 · Received October 12, 2016

    Report

    Report Number
    0001825034-2016-04095
    Event Type
    Injury
    Date Received
    October 12, 2016
    Report Date
    May 8, 2017
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    JDR
    PMA / PMN Number
    PK141263
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. IT WAS RELAYED THAT AN OLDER VERSION OF THE SURGICAL TECHNIQUE WAS USED; THEREFORE, AN EXPRESSBRAID WAS NOT USED IN THE SURGERY. THIS LIKELY LED TO THE FAILURE OF THE DEVICE. ROOT CAUSE DETERMINED TO BE INCORRECT SURGICAL TECHNIQUE. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A DISTAL BICEP REATTACHMENT REVISION HAS BEEN INDICATED DUE TO UNKNOWN POSTOPERATIVE FAILURE OF THE FIXATION SYSTEM. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672660 2.9MM TOGGLELOC WITH ZIPLOOP WITH NEEDLES, #2 MAXBRAID STAPLE, FIXATION JDR BIOMET SPORTS MEDICINE N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention