BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 7989758 · Received October 22, 2018

    Report

    Report Number
    1221934-2018-55010
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    August 26, 2018
    Report Date
    September 27, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE, DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO PICTURES WERE PROVIDED. THIS COMPLAINT IS NOT CONFIRMED. AS REPORTED THE ANCHOR BROKE DURING INSERTION. NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART 210813 LOT L937016 COMBINATION AND NO NONCONFORMANCE WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 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 · 0

    ADDITIONAL EVENT INFORMATION RECEIVED ON 10/29/2018. THE ANCHOR BREAK IS ON PROXIMAL END. THE INSERTION WAS NOT OFF AXIS. THE PATIENT¿S BONE QUALITY WAS NOTED TO BE STRONG. EVERYTHING WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NEW ANCHOR IN A NEW DRILL HOLE. THE ORIGINAL BONE HOLE WAS NOT USED BUT ADDITIONAL BONE HOLE WAS MADE TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT BEING RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A HIP ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON ANCHOR DEVICE BROKE DURING INSERTION. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833157 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI MEDOS INTERNATIONAL SàRL L937016 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1 Other