BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII QA+ O/C CP-2 *EA

    MDR report key: 7349270 · Received March 19, 2018

    Report

    Report Number
    1221934-2018-50315
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 22, 2018
    Report Date
    February 22, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705008612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE TIP WAS BROKEN. THE DISTAL END IS BENT OUT OF POSITION AND THERE IS PROCEDURAL DEBRIS REMAINING ON THE END. THIS SUGGESTS THERE WAS EXCESSIVE FORCE APPLIED TO THE DISTAL TIP FROM STRIKING ANOTHER INSTRUMENT OR A HARD SURFACE SUCH AS BONE. THE ROOT CAUSE CAN BE ATTRIBUTED TO DEVICE MISUSE BY APPLYING EXCESSIVE FORCE ON THE DEVICE TIP. 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 PAPERWORK REVIEWED. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES RELEASED TO DISTRIBUTION. AT THIS POINT IN 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 AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT DHR REVIEW: PART NUMBER:222983, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 02.09.2016, MANUFACTURING DATE: 23.08.2016, EXPIRATION DATE: 31.07.2019, SUPPLIER: N/A, MANUFACTURING SITE: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4) - INCOMPLETE. THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR GII ANCHOR WITH ORTHOCORD BROKE AT THE TIP UPON INSERTION DURING AN OSTEOCHONDROMA REMOVAL. THE ANCHOR AND DEBRIS WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE IN THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CUSTOMER COULD NOT PROVIDE THE BONE QUALITY OF THE PATIENT. THE DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192168 GII QA+ O/C CP-2 *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US 3919780 10886705008612

    Patients

    Seq Age Sex Outcome Treatment
    1