BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 8245079 · Received January 14, 2019

    Report

    Report Number
    1221934-2018-51533
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    January 25, 2016
    Report Date
    January 25, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION UNDER MAGNIFICATION CONFIRMS THAT THE ANCHOR IS BROKEN IN TWO PLACES, NEAR THE DISTAL AND PROXIMAL ENDS. TYPICALLY, ANCHOR BREAKAGES ARE ASSOCIATED WITH OFF -AXIS INSERTION, LEVERING DURING INSERTION OR HARD BONE QUALITY. NO TECHNIQUE INFORMATION WAS PROVIDED THAT WOULD SUGGEST IF THE AFOREMENTIONED CAUSES CONTRIBUTED TO THIS EVENT. ALTHOUGH THE COMPLAINT CAN BE CONFIRMED, WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 210813-LOT #3864877 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. AT THIS POINT IN TIME, BASED ON THE OVERALL COMPLAINT RATE, 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. THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A SHOULDER PROCEDURE WHEN INSERTING THE CUSTOMER'S GRYPHON P BR ANCHOR WITH ORTHOCORD DUAL SUTURE, THE ANCHOR SNAPPED IN HALF AND SPILT FROM THE DISTAL TIP TO MIDWAY UP THE ANCHOR. THE SALES REP STATED THAT THE SURGEON REMOVED THE BROKEN ANCHOR AND STATED THAT NO DEBRIS IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE PATIENT HAD AN AVERAGE BONE QUALITY. THE SALES REP STATED THAT A HARD BONE DRILL WAS USED WITH THE ANCHOR AND THAT SHE WAS UNSURE IF THE SURGEON WAS OFF ANGLE WHEN INSERTING THE ANCHOR. THE DEVICE WILL BE RETURNING FOR EVALUATION. 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
    37508 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3864877 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR