BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX FEM2.7MM B/T/B XPIN

    MDR report key: 8277826 · Received January 25, 2019

    Report

    Report Number
    1221934-2018-53809
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Report Date
    June 7, 2017
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705000883
    PMA / PMN Number
    K150209
    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. VISUAL OBSERVATION CONFIRMS THE REPORTED FAILURE THAT THE TIPS OF THE SLEEVE IS BROKEN AND HEAVILY DAMAGED. THE DEVICE ALSO APPEARED TO BE IN WORN CONDITION AND POSSIBLY HAS SEEN HEAVY USE. THIS TYPE OF FAILURE IS CONSISTENT WITH EXCESS FORCE BEING EXERTED DURING USE OF THE DEVICE DAMAGING THE TIP. THIS FAILURE CAN BE ATTRIBUTED TO USER TECHNIQUE. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO SIMILAR COMPLAINT OF ANY KIND 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 210127-LOT #L328685 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. 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. 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 AN UNSPECIFIED SURGICAL PROCEDURE OF THE KNEE, IT WAS OBSERVED THAT THE EXTERNAL TIP ON THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE BROKE WHEN REMOVING ONE OF THE TWO SLEEVES AFTER THE PLACEMENT OF THE PINS. ACCORDING TO THE REPORTER, THE EVENT PREVENTED THE REMOVAL OF THE SLEEVE WITH THE CLAMP PROVIDED. IT WAS REPORTED THAT THE SURGEON HAD TO USE ANOTHER CLAMP. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS NO NEED TO USE ANOTHER KIT. IT WAS REPORTED THAT DURING PLACING, THE SURGEON HAD TO FORCE ABNORMALLY ON THE SLEEVE AND HE HAD DIFFICULTY TO PLACE AND REMOVE THE INTERLOCKING TROCAR. THERE WAS A DELAY OF FIVE MINUTES IN THE SURGERY. IT WAS REPORTED THAT THE TIP OF THE SLEEVE DID NOT FALL INTO THE PATIENT. 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
    70325 RIGIDFIX FEM2.7MM B/T/B XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L328685 10886705000883

    Patients

    Seq Age Sex Outcome Treatment
    1