BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD

    MDR report key: 5613928 · Received April 27, 2016

    Report

    Report Number
    1221934-2016-10167
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    March 29, 2016
    Report Date
    March 29, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    PK140324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE WHITE, TENSIONING SUTURE IS BROKEN AND FRAYED, CONFIRMING THIS COMPLAINT. THIS SUTURE IS DESIGNED TO WITHSTAND EXTREMELY HIGH FORCE AND IS NOT EASILY BROKEN BY HAND. THE PROBABLE ROOT CAUSE IS RUBBING SUTURE ON ANY SHARP EDGE WHILE TENSIONING. A SHARP EDGE WOULD CREATE A STRESS POINT IN THE SUTURE, CAUSING IT TO FRAY AND BREAK. A BATCH RECORD REVIEW FOR THE FINISHED GOOD LOT WAS CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. THE DEVICE WAS REVIEWED WITH THE QUALITY ENGINEER RESPONSIBLE FOR THE RIGID LOOP ADJUSTABLE PRODUCT WHO BASED ON THE INFORMATION AVAILABLE COULD NOT DETERMINE A ROOT CAUSE OTHER THAN THE ONE STATED ABOVE. A LOT REVIEW WAS PERFORMED ON THE LOT OF THE BROKEN SUTURE AND THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER COMPLAINT FOR THIS LOT OF (B)(4) DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME NO FURTHER CORRECTIVE ACTION IS REQUIRED. HOWEVER, DEPUY 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IN A ACL PROCEDURE AFTER DE PULL AND THE FLIP OF THE STANDARD RIGIDLOOP ADJ. WHEN THE ADJUSTING WAS DONE THE WIRE BROKE. THIS APPEARED TO BE NO PROBLEM BUT AFTER THE CYCLING OF THE KNEE THE WHOLE LOOP BROKE. THE PROCEDURE WAS REDONE WITH A LONG RIGIDLOOP ADJ WITH NO ADDITIONAL PROBLEMS. BOTH PROCEDURES WERE DONE ACCORDING TO THE SURGICAL TECHNIQUE. THIS EXTENDED THE PROCEDURE BY 60 MINUTES. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM THE AFFILIATE ON 4-1-2016. SUTURE BROKE OUTSIDE THE PATIENT INITIALLY AND THEN THE KNOT BROKE AT FEMORAL LEVEL THE SURGEON PULLING ON THE SUTURE WITH HANDS IF USING SNAPS PROVIDE HOW THE DEVICE WAS USED. - N/A. IT WAS EASY TO REMOVE THE ORIGINAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267593 RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD MITEK ACL IMPLANTS MBI DEPUY MITEK 3882236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other