BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3101362 · Received May 9, 2013

    Report

    Report Number
    2530088-2013-00781
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE RAW MATERIAL WAS VERIFIED AS CORRECT, AND THE SD25 FORM CANNOT BE MEASURED BECAUSE OF DAMAGE, COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. OUR INVESTIGATION HAS SHOWN THAT THE T25 RECESS IS STRIPPED AS COMPLAINED. THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE DEVICE WAS FORWARDED TO THE RESPONSIBLE PRODUCT MANAGER AND HE DID PERFORM A FUNCTION TEST. EVEN WITH THE DAMAGED RECESS IT WAS STILL POSSIBLE TO INSERT AND REMOVE THE SCREW FROM A BLOCK. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY PRODUCT FAULT. THE EXACT CAUSE OF THIS OCCURRENCE CANNOT BE DEFINED. IT IS POSSIBLE THAT THIS DAMAGE WAS CAUSED BY HIGH TORQUE IN COMBINATION WITH A POSSIBLY NOT COMPLETELY INSERTED SCREWDRIVER. THE CONDITION OF THE SCREWDRIVER TIP MAY ALSO HAVE PLAYED A CERTAIN ROLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. REVIEW OF THE DHR SHOWED ONE NONCONFORMANCE FOR DATA ENTRY ERROR AND IS NOT RELEVANT TO THE COMPLAINT. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, IT WAS REPORTED THE MATRIX PEDICLE SCREW STRIPPED. UPON PLACING THE SCREW IN S1, THE SCREWDRIVER DETACHED FROM THE SCREW CAUSING THE T25 SHAFT TO SLIP FROM THE SCREW. SUBSEQUENTLY THE SCREWS RECESS SPACE BECAME DAMAGED. THE SURGEON NEEDED TO REMOVE THE SCREW FOR REPOSITIONING BUT WAS UNABLE TO GET THE T25 SHAFT TO SEAT IN THE SCREW AND CONSEQUENTLY COULD NOT BACK OUT THE SCREW. IT TOOK THE SURGEON A NUMBER OF ATTEMPTS BEFORE HE WAS ABLE TO REMOVE THE SCREW. THIS OCCURRENCE CAUSED A 20 MINUTE DELAY IN THE PROCEDURE. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204284 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES BRANDYWINE 6654382

    Patients

    Seq Age Sex Outcome Treatment
    1