BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 12 DEGREE PEEK

    MDR report key: 8157582 · Received December 12, 2018

    Report

    Report Number
    1221934-2018-55656
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    January 1, 2018
    Report Date
    September 13, 2018
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MBI
    UDI-DI
    10886705026012
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THERE WERE FOUR COMPLAINT DEVICES REPORTED THAT WERE USED DURING ONE PROCEDURE. THREE OF THE DEVICES WERE FROM THE SAME LOT AND THE 4TH DEVICE WAS FROM A DIFFERENT LOT. THE FOUR DEVICES WERE RECEIVED, AND AN EVALUATION WAS PERFORMED ON EACH DEVICE. THERE IS NO LOT NUMBER ON THE DEVICES, THEREFORE WE CANNOT IDENTIFY WHICH ONES ARE FROM WHICH OF THE TWO LOTS REPORTED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR BOTH PRODUCT LOT NUMBER COMBINATIONS; PRODUCT CODE (B)(4)/ LOT # L915368 (QTY 3) AND PRODUCT CODE (B)(4)/ LOT # L982352. NO NON-CONFORMANCES WERE IDENTIFIED FOR EITHER ONE. THERE WERE PICTURES OF THE DEVICES PROVIDED AFTER THE REPORTED FAILURE. THE DEVICES WERE EVALUATED AND THE EVALUATIONS OF THE FOUR DEVICES ARE AS FOLLOWS: DEVICE 1 OF 4: VISUAL OBSERVATIONS REVEALED BOTH THE IMPLANTS GOT STUCK AT THE DISTAL END OF WHITE SLEEVE STOP TUBE OF THE DEVICE. THIS COMPLAINT CAN BE CONFIRMED. THE SHAFT IS SLIGHTLY BENT/DEFORMED NEAR THE DISTAL END OF THE DEVICE. BOTH IMPLANTS WERE INTACT AND LINKED TOGETHER WITH THE SUTURE, NO ANOMALIES WERE FOUND ON THE IMPLANTS. THE PUSHER ROD WAS EVALUATED, VIA FUNCTIONAL TESTING THE TRIGGER WAS PULLED. A CLICK WAS HEARD, INDICATING THE PUSHER ROD BY ITSELF WAS FUNCTIONAL. ONE OF THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE IS USER TECHNIQUE IN APPLYING THE DEVICE WITH TOO MUCH FORCE, BUT DUE TO THE CURRENT CONDITION OF THE DEVICE WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. DEVICE 2 OF 4: FROM THE PICTURE PROVIDED, IT IS SHOWN THAT BOTH THE IMPLANTS GOT STUCK AT THE DISTAL END OF WHITE SLEEVE STOP TUBE OF THE DEVICE BUT WHEN THE DEVICE WAS VISUALLY OBSERVED THE TWO IMPLANTS HAVE FELL APART FROM THE DEVICE ALONG WITH THE SUTURE. THIS COMPLAINT CAN BE CONFIRMED. BOTH IMPLANTS WERE INTACT AND LINKED TOGETHER WITH THE SUTURE, NO ANOMALIES WERE FOUND ON THE IMPLANTS. THE PUSHER ROD WAS EVALUATED, VIA FUNCTIONAL TESTING THE TRIGGER WAS PULLED. A CLICK WAS HEARD, INDICATING THE PUSHER ROD BY ITSELF WAS FUNCTIONAL. ONE OF THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE IS USER TECHNIQUE IN APPLYING THE DEVICE WITH TOO MUCH FORCE, BUT DUE TO THE CURRENT CONDITION OF THE DEVICE WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. DEVICE 3 OF 4: VISUAL OBSERVATION REVEALS THAT BOTH THE IMPLANTS WERE NOT RETURNED AND THERE WERE NO ANOMALIES ON THE DEVICE. THE COMPLAINT CAN BE CONFIRMED. THE PUSHER ROD WAS EVALUATED, VIA FUNCTIONAL TESTING THE TRIGGER WAS PULLED. A CLICK WAS HEARD, INDICATING THE PUSHER ROD BY ITSELF WAS FUNCTIONAL. ONE OF THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE IS USER TECHNIQUE IN APPLYING THE DEVICE WITH TOO MUCH FORCE, BUT DUE TO THE CURRENT CONDITION OF THE DEVICE WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. DEVICE 4 OF 4: VISUAL OBSERVATION REVEALS THAT BOTH THE IMPLANTS WERE NOT RETURNED AND THERE WERE NO ANOMALIES ON THE DEVICE. THE COMPLAINT CAN BE CONFIRMED. THE PUSHER ROD WAS EVALUATED, VIA FUNCTIONAL TESTING THE TRIGGER WAS PULLED. A CLICK WAS HEARD, INDICATING THE PUSHER ROD BY ITSELF WAS FUNCTIONAL. ONE OF THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE IS USER TECHNIQUE IN APPLYING THE DEVICE WITH TOO MUCH FORCE, BUT DUE TO THE CURRENT CONDITION OF THE DEVICE WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. 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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DEVICES DID NOT TRIGGER. NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON (B)(6) 2018 STATING THAT THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE SURGERY WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICES ARE AVAILABLE FOR RETURN FOR EVALUATION AND THAT THE DEVICE WAS ONLY FIRED ONCE WITH FORCE BUT 2 IMPLANTS DEPLOYED AT THE SAME TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 FROM THE AFFILIATE CONFIRMING THAT THERE ARE 4 TOTAL PRODUCTS LISTED AS IMPACTED PRODUCTS (LOT L915368, QTY 3; LOT L982352, QTY 1 AND THAT ALL 4 PRODUCTS EXPERIENCED FAILURES OF DOUBLE DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997165 TRUESPAN 12 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SARL L915368 10886705026012

    Patients

    Seq Age Sex Outcome Treatment
    1