BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIXTRANSTEND PEEK1 IMPL SYS

    MDR report key: 7076449 · Received December 1, 2017

    Report

    Report Number
    1221934-2017-50026
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 2, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    UDI-DI
    10886705020300
    PMA / PMN Number
    K102298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR PHYSICAL EVALUATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE THE REPORTED DEVICE FAILURE CANNOT BE DETERMINED. PER THE PRODUCT IFU, THIS DEVICE IS NOT INDICATED FOR USE FOR A PATELLAR TENDON REPAIR. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT; THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE RECORDS REVIEWED. REVIEW OF THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR COMPLAINT DEVICE FOR THIS LOT NUMBER (INCLUDED IN THIS COMPLAINT). AT THIS 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 TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4). SEE ASSOCIATED MEDWATCH: 1221934-2017-50021; 1221934-2017-50020; 1221934-2017-50024.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). RELATED MEDWATCH: 1221934-2017-50021; 1221934-2017-50020; 1221934-2017-50024.

    Description of Event or Problem · 1

    DR. XXXX WAS USING DEPUY MITEK HEALIX TRANSTEND PEEK ANCHOR #222276 (X2) AND DEPUY MITEK HEALIX TRANSTEND (PEEK1) IMPLANT SYSTEM (X2) TO REPAIR A PATELLA TENDON AND THEY ALL BROKE. ENDED UP USING A ARTHREX PRODUCT. PER ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON DECEMBER 26, 2017: I BELIEVE MOST OF THESE WERE ANSWERED IN MY INITIAL REPORT. ALL DEVISES WERE DISCARDED DURING SURGERY AND NOT AVAILABLE TO GET LIT NUMBERS BY THE TIME THEY WERE REPORTED TO ME. I WAS NOT AT THE CASE. THE DEVISES WERE USED DURING THE CASE AND THE ALTERNATES WERE THE OTHER ONES THAT BROKE UNTIL THE DECIDED TO USE ANOTHER BRAND PRODUCT. I WILL ASK HOW MUCH DELAY THERE WAS BUT I WOULD IMAGINE IT WAS MORE THAN 30 MIN SINCE THEY WENT THRU 5 PRODUCTS. NO PRICES LEFT IN THE PATIENT. SURGERY WAS COMPLETED. ACCORDING TO THEM THE PROCEDURE WAS DONE CORRECTLY. PER ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON DECEMBER 26, 2017: THE CHARGE NURSE INDICATED THERE WAS NO DELAY AND NOTHING LEFT IN. SHE ALSO SAID SHE MAY HAVE PICTURES OF THE BOXES WITH THE SERIAL NUMBER. PER ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON DECEMBER 27, 2017: THE DELAY WAS ABOUT 15 MINUTES. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    DR. XXXX WAS USING DEPUY MITEK HEALIX TRANSTEND PEEK ANCHOR #222276 (X2) AND DEPUY MITEK HEALIX TRANSTEND (PEEK1) IMPLANT SYSTEM (X2) TO REPAIR A PATELLA TENDON AND THEY ALL BROKE. ENDED UP USING A ARTHREX PRODUCT. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION:EXTENDER OR TIME. ACTION TAKEN FOR PROCEDURE:USED ARTHREX PRODUCT TO COMPLETE THE PROCEDURE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855858 HEALIXTRANSTEND PEEK1 IMPL SYS SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MAI DEPUY MITEK 3894872 10886705020300

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR