BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII QA+ W #2 ORTHOCORD

    MDR report key: 4100260 · Received September 18, 2014

    Report

    Report Number
    1221934-2014-00413
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    September 30, 2013
    Report Date
    September 1, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K051989
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED AND THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE CHIEF MEDICAL OFFICER OF THE CLINIC, IT WAS STATED THAT THERE MUST HAVE BEEN A THREAD BREAKAGE IN THE RE-INSERTION SITE OF THE BONE. THE THREAD WAS PROBABLY DAMAGED BY ABRASION OF THE DRILL HOLE, SO THERE WAS RE-RUPTURE. HOWEVER, THIS CANNOT BE CONFIRMED BY MITEK EVALUATION TEAM WITHOUT ANY PHOTOGRAPHIC EVIDENCE OR PHYSICALLY EXAMINING THE DEVICE. A 3 YEAR COMPLAINT HISTORY REVIEW OF THIS PRODUCT DID NOT RESULT IN ANY SIMILAR INSTANCES. THIS CASE SEEMS TO BE AN ANOMALY AND AN ISOLATED INCIDENT. AT THIS POINT IN TIME, NO FURTHER ACTIONS ARE 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.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK HOWEVER IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    PATIENT HAD ACCIDENT WITH RUPTURE OF DISTAL BICEPS TENDON. REFIXATION USING MITEK GII ANCHOR 2,4, CODE-NO. 222983 ON (B)(6) 2013. DIAGNOSIS OF RERUPTURE ON (B)(6) 2013. PATIENT HAD TO GET REOPERATED AND RE-RUPTURE HAD SUPPOSEDLY MATERIAL FATIGUE AS ROOT CAUSE. RE-RUPTURE OF REFIXATED DISTAL BICEPS TENDON AFTER 3 OR 5 DAYS.

    Description of Event or Problem · 1

    PATIENT HAD ACCIDENT WITH RUPTURE OF DISTAL BICEPS TENDON. REFIXATION USING MITEK GII ANCHOR 2,4, CODE-NO. 222983 ON (B)(6) 2013. DIAGNOSIS OF RERUPTURE ON (B)(6) 2013. PATIENT HAD TO GET REOPERATED AND RE-RUPTURE HAD SUPPOSEDLY MATERIAL FATIGUE AS ROOT CAUSE. RE-RUPTURE OF REFIXATED DISTAL BICEPS TENDON AFTER 3 OR 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580249 GII QA+ W #2 ORTHOCORD SOFT-TISSUE ANCHOR, NON-BIODEGRADABLE JDR DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R