BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 24 DEGREE PEEK

    MDR report key: 9355457 · Received November 21, 2019

    Report

    Report Number
    1221934-2019-59667
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 30, 2019
    Report Date
    November 5, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705026029
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION: H6: METHOD CODES: DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/SERIAL NUMBER L991741, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER L991741, AND NO NON-CONFORMANCES WERE IDENTIFIED. SINCE THE COMPLAINT DEVICE WAS DISCARDED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED ARTHROSCOPIC SURGICAL PROCEDURE, IT WAS OBSERVED THAT A TRUESPAN SUTURE OF 24 DEGREES FAILED DURING PLACEMENT. ACCORDING TO THE REPORT, WHEN THE SURGEON CROSSED THE MENISCUS AND FIRED THE SUTURE, THE PEEK IMPLANTS WERE OBSERVED TO BE OUTSIDE THE MENISCUS. IT WAS REPORTED THAT ANOTHER MENISCAL SUTURE OF 24 DEGREES WAS OPENED BUT THE THREAD BROKE AT A TIME WHEN THE SURGEON WAS TENSING THE THREAD. IT WAS REPORTED THAT THE SURGEON HAD TO USE A LONG CLAMP AND CUT THE THREAD WITH A MENISCUS CLAMP. THERE WAS A DELAY OF FIVE TO TEN MINUTES TO COMPLETE THE SURGERY WITH A SECOND SUTURE. IT WAS REPORTED THAT THERE WERE NO DIFFICULTY ALIGNING INSTRUMENTS REQUIRED FOR INSERTION PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO EXCESSIVE FORCE NEEDED TO INSERT THE DEVICE. IT WAS REPORTED THAT THE COLOR OF THE SUTURE WAS WHITE. IT WAS REPORTED THAT THE SUTURE WAS NOT IN CONTACT WITH AN INSTRUMENT BEFORE BREAKAGE. IT WAS REPORTED THAT A SUTURE PASSER AND SUTURE CUTTER WERE USED IN THE PROCEDURE. IT WAS REPORTED THAT THE SURGEON USED PROPER SUTURE MANAGEMENT DURING SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150480 TRUESPAN 24 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL 228152 L991741 10886705026029

    Patients

    Seq Age Sex Outcome Treatment
    1