BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 6076402 · Received November 3, 2016

    Report

    Report Number
    3003875359-2016-10576
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    KWQ
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 03.617.993, LOT # 1944271. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JULY 25, 2008. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE 3.0 MM CERVICAL SPINE LOCKING SCREW (PART NUMBER 04.617.816, LOT NUMBER UNKNOWN), ANGLED AWL (PART NUMBER 03.617.993, LOT NUMBER 1944271) AND THE SCREWDRIVER SHAFTS THAT WERE STATED AS STRIPPED PER COMPLAINT CONDITION . THE SUBJECT DEVICES WERE RETURNED WITH THE COMPLAINT CONDITION STATING THE RETURNED DEVICES WERE EXAMINED AND IN EACH INSTANCE THE COMPLAINT CONDITIONS WERE ABLE TO BE CONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. RELEVANT DRAWINGS FOR THE RETURNED DEVICES WERE REVIEWED (CURRENT REVISION AND FROM TIME OF MANUFACTURE) AND IN EACH INSTANCE THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. A DEVICE HISTORY REVIEW WAS PERFORMED WHEN APPLICABLE AND NO NON-CONFORMANCE RECORDS (NCRS) OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITIONS. COMPLAINT HISTORIES FOR THE RETURNED DEVICES WERE REVIEWED AND EACH CALCULATED OCCURRENCE RATE WAS FOUND TO BE ADEQUATELY ADDRESSED BY THE SYSTEM RISK ASSESSMENT NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED FOR THE CERVICAL SPINE LOCKING SCREWS, HOWEVER THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH ATTEMPTED SCREW INSERTION WHILE THE DRIVER TIP IS NOT FIRMLY SEATED IN THE SCREW¿S DRIVE RECESS. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED FOR THE SCREWDRIVER SHAFTS; THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH ROUGH HANDLING AND/OR THE APPLICATION OF EXCESSIVE FORCE DURING SCREW INSERTION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED FOR THE AWL; THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH ROUGH HANDLING AND/OR THE APPLICATION OF EXCESSIVE FORCE DURING USE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION. WHILE USING A ZERO-P STANDALONE DEVICE TO CORRECT A DEGENERATIVE FUSION, SIX (6) SCREWS AND A SCREWDRIVER STRIPPED AND THE TIP OF AN AWL BROKE. WHILE AWLING TO CREATE THE PATHWAY FOR A SCREW, THE TIP OF THE AWL BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE TIP EASILY WITHOUT ADDITIONAL MEDICAL INTERVENTION. THE SURGEON DISCONTINUED USING THE AWL AND COMPLETED THE PATHWAY USING A DRILL. DURING FINAL TIGHTENING OF THE SAME SCREW THE SURGEON WAS CREATING A PATHWAY FOR, AS THE SCREW WAS ALMOST IMPLANTED THE SCREWDRIVER STRIPPED. THE SURGEON CONTINUED TO TURN THE SCREW AND THE SCREW STRIPPED AS WELL. REPORTEDLY, TOTAL OF SIX (6) LOCKING SCREWS WERE INVOLVED DURING THE SAME SURGERY AND ALL SIX (6) SCREWS WERE STRIPPED. AN ALTERNATE DRIVER WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN HOW LONG THESE DEVICES HAVE BEEN IN USE. THERE WAS LESS THAN ONE MINUTE SURGICAL DELAY TO CHANGE OUT THE DRIVER. THE PATIENT WAS REPORTED AS STABLE POSTOPERATIVELY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) ANGLED AWL. THIS IS REPORT 7 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726747 2.0MM ANGLED AWL APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES HAGENDORF 1944271

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE (1) UNKNOWN DRILL