BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGDFIX FEM3.3MM ST BR XPIN KIT

    MDR report key: 8043730 · Received November 6, 2018

    Report

    Report Number
    1221934-2018-55214
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 30, 2018
    Report Date
    October 30, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001309
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT IS NOT CONFIRMED. WITHOUT PHYSICALLY EVALUATING THE DEVICE, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (210816), LOT NUMBER (L883103). COMBINATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S RIGIDFIX 3.3MM FEMORAL CROSS PIN KIT SHEATH BROKE WHILE ATTEMPTING TO REMOVE FROM THE PATIENT. THE SALES REP STATED THAT WHILE INSERTING THE IMPLANT, THE WIRE ARMS SNAPPED OFF WHILE IT WAS BEING DRILLED IN AND THE PROXIMAL END OF THE SHEATH SEPARATED FROM THE DISTAL END. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE. THE SALES REP STATED THAT THE REMAINDER OF THE SHEATH WAS LEFT IN THE PATIENT AND THAT IS HOW THE CASE WAS COMPLETED. THEY TOOK AN X-RAY AND CHOSE TO LEAVE IT IN. THE SALES REP STATED THERE IS NO PLAN FOR SURGICAL INTERVENTION. THERE WAS A FIFTEEN MINUTE DELAY TO REMOVE THE PROXIMAL END OF THE SHEATH AND END THE SURGERY. THE DEVICE IS NOT RETURNING AS IT IS IMPLANTED IN 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
    883165 RGDFIX FEM3.3MM ST BR XPIN KIT SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L883103 10886705001309

    Patients

    Seq Age Sex Outcome Treatment
    1