BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI CANCELLOUS AXON(TM) SCREW 26MM THREAD LENGTH

    MDR report key: 4348821 · Received December 20, 2014

    Report

    Report Number
    2530088-2014-10442
    Event Type
    Malfunction
    Date Received
    December 20, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 23, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    PK141897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE AXON TOP LOADING SCREW AND COMPONENTS EXHIBIT POST PRODUCTION/ACCEPTANCE DAMAGE THAT INCLUDES: 2.5MM HEX FACE HAS NICKS/SCRATCHES RADIATING INTO BLASTED AREA OF THE SCREW. THERE ARE NICKS AND SCRATCHES ON THE INTERNAL DIAMETER ON THE NEUTRAL BODY. THE RAW MATERIAL CANNOT BE MEASURED BECAUSE THE PRODUCT IS ASSEMBLED. ALL OTHER FEATURES RELEVANT TO COMPLAINT CONDITION MEETS SPECIFICATION, COMPLAINT IS UNCONFIRMED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HISTORY REPORT (DHR) REVIEW FOUND NONCONFORMANCE REPORTS (NCR) (1097589) FOR UNDERSIZED SPHERICAL DIAMETER ON SCREW¿ PART NO. 405.526, LOT #7558422. THE PARTS WERE 100% INSPECTED AT OP 70 WITH THE NONCONFORMING PRODUCT BEING SCRAPPED. THE SCREW SPHERICAL DIAMETER BEING UNDERSIZED WOULD NOT CAUSE THE CAP TO BE SLIPPY (SLIPPING) OR INSIDE SCREW THREAD TO BE BROKEN. UNDERSIZED SPHERICAL DIAMETER WOULD HAVE NO AFFECT ON COMPLAINT CONDITION. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT. DHR REVIEW FOUND NCR (1072634) FOR WRONG RAW MATERIAL TESTING BEING USED ¿ PART NO. 21018, LOT #7375397. RAW MATERIAL WAS INSPECTING TO AMS 2632 INSTEAD OF AMS 2631. DISPOSITION WAS 'USE AS IS', BECAUSE AMS 2632 IS MORE STRINGENT THAN AMS 2631. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT. DHR REVIEW FOUND NCR (1072881) FOR LOT NUMBER NOT BEING ETCHED ON RAW MATERIAL ¿ PART NO. 21018, LOT #7375397. RAW MATERIAL WITH ISOLATED BAR WITHOUT LASER ETCH WAS SCRAPPED, MISSING ETCH WOULD NOT CAUSE THE CAP TO BE SLIPPY OR INSIDE SCREW THREAD TO BE BROKEN. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING THE OPEN REDUCTION AND INTERNAL FIXATION OF POSTERIOR LUMBAR SURGERY, WHEN THE CAP WAS SCREWED INTO THE NAIL, THE CAP WAS SLIPPING. THE SURGEON ALSO NOTED THE INSIDE SCREW THREAD WAS ALSO BROKEN. TOTALLY 2 SCREWS AND 4 CAPS HAD PROBLEMS. THE SURGEON HAD TO CHANGE TO ANOTHER ONE TO COMPLETE. THERE WAS NO REPORT ON PATIENT INJURY. THIS IS REPORT 5 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839313 3.5MM TI CANCELLOUS AXON(TM) SCREW 26MM THREAD LENGTH APPLIANCE,FIXATION,SPINAL INTERLAMINAL KWP SYNTHES BRANDYWINE 7558422

    Patients

    Seq Age Sex Outcome Treatment
    1