BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMA NEEDLE KIT Ø3.3 CANNUL W/SIDE-OPE

    MDR report key: 3004022 · Received March 14, 2013

    Report

    Report Number
    8030965-2013-00877
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE STERILE PACKAGE IS INDEED PERFORATED IN ONE CORNER AS COMPLAINED. AFTERWARDS IT IS IMPOSSIBLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. AS THIS ARTICLE DID PASS THE FINAL INSPECTION WITH NO FINDINGS AND AS THE VISIBLE MARK OF THE SEALING SHOWS THAT THE PACKAGE WAS SEALED AFTER MANUFACTURING WE CAN ONLY ASSUME THAT THIS DAMAGE WAS CAUSED BY ANY OCCURRENCE DURING TRANSPORTATION. THIS WOULD ALSO EXPLAIN THE DIFFERENT VISIBLE DENTS AT THE BOX.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED, EVALUATION NOT BEGUN THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013 SURGEON WAS TRYING TO USE PFNA AUGMENT CEMENT. HE TOOK THE PFNA AUGMENT NEEDLE KIT OUT OF THE BOX TO PREPARE IT FOR THE PROCEDURE AND NOTICED THE SIDE OPENING CANNULA HAD PERFORATED THE PACKAGING. THE OUTER BOX WAS INTACT AND SHOWED NO SIGN OF DAMAGE. THE SEAL WAS ALSO INTACT. INTERNAL PACKAGING SEEMED TO BE INTACT. IT WAS NOT POSSIBLE FOR THE SURGEON TO FINISH THE CASE USING THE AUGMENT. SURGEON CONTINUED THE PROCEDURE WITHOUT THE USE OF AUGMENT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107561 TRAUMA NEEDLE KIT Ø3.3 CANNUL W/SIDE-OPE GAA SYNTHES GMBH AKB411

    Patients

    Seq Age Sex Outcome Treatment
    1