BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY

    MDR report key: 6411232 · Received March 16, 2017

    Report

    Report Number
    1221934-2017-10107
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    February 22, 2017
    Report Date
    February 22, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K140643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A DHR REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT ANY INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. 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. (B)(4). ASSOCIATED MEDWATCH: 1221934-2017-10108.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL THE SURGEON INSERTED THE REPORTED 210820 GRYPHON PROKNOT (LOT #3909702). HE TRIED TO TIE UP THE TISSUE WITH THE SUTURE. BUT THE SUTURE BECAME ENTANGLED. SO HE REMOVED THE PROKNOT. NEXT, HE UTILIZED THE ORIGINAL BONE HOLE AND TRIED TO INSERT THE REPORTED 210813 GRYPHON ORTHOCORD (LOT #3916954). BUT HE COULD NOT SECURELY FIX THIS ORTHOCORD IN THE BONE HOLE. ALTHOUGH HE TRIED TO TIE UP THE TISSUE, THE ORTHOCORD BECAME LOOSE. SO, HE REMOVED IT. FINALLY, HE NEWLY MADE A BONE HOLE AND INSERTED A REPLACING 210820 GRYPHON PROKNOT AND COMPLETED THE SURGERY. TOTAL SURGICAL DELAY WAS 20 MINUTES. ALL THE REPORTED DEVICES WERE NEW. THE DEVICES ARE NOT GOING TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191786 GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY MITEK ANCHOR IMPLANTS MAI DEPUY MITEK 3909702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other