BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX FEM 3.3MM S/T XPIN

    MDR report key: 8266570 · Received January 22, 2019

    Report

    Report Number
    1221934-2018-52759
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Report Date
    November 22, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HTY
    UDI-DI
    10886705000890
    PMA / PMN Number
    K974341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE REPORTED FAILURE COULD BE CONFIRMED FROM THE VISIBLE STRIATION MARKS ON THE TROCAR WHERE IT HAD COLD WELDED WITH THE SLEEVE. HISTORICALLY, THIS TYPE OF FAILURE HAS BEEN ATTRIBUTED TO USER TECHNIQUE ISSUE. THE LOCATION OF THE TROCAR INTERLOCKING PINS IS SUPERIOR TO THE MATING PORTION OF THE SLEEVE. IF THE PINS ARE NOT SEATED WITHIN THESE GROVES THEN THE TROCAR IS SPINNING WITHIN THE GUIDE SLEEVE CAUSING ENOUGH HEAT AND FRICTION TO CAUSE THE "WELDING" OF THE TWO PARTS. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 210133, LOT 3901120 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING FEMORAL FIXATION OF THE ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX FEM 3.3MM S/T XPIN SLEEVE DEVICE WAS DIFFICULT TO REMOVE. ACCORDING TO THE REPORTER, THE SLEEVE WAS BLOCKED AT THE TROCAR. IT WAS FURTHER REPORTED THAT THE TROCAR AND THE SLEEVE WERE WELDED TOGETHER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60946 RIGIDFIX FEM 3.3MM S/T XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE HTY DEPUY MITEK LLC US 3901120 10886705000890

    Patients

    Seq Age Sex Outcome Treatment
    1