BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 5806434 · Received July 19, 2016

    Report

    Report Number
    3003875359-2016-10419
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 5, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    KWQ
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT AGE & WEIGHT NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 03.SEP.2008, EXPIRY DATE, PART #03.617.993 ¿ LOT #1966903. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    A MANUFACTURING INVESTIGATION SUMMARY WAS PERFORMED. THE REPORT INDICATES THAT THE: AFFECTED PART DESCRIPTION: AWL Ø2 ANGL PART #03.617.993, LOT #1966903 LOT RELEASE DATE: 03.09.2008, REPORTED ISSUE: IT WAS REPORTED THAT DURING A C6/7 ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGEON WAS USING THE ANGLED AWL TO BREAK THE CORTEX AND CREATE THE HOLES FOR THE SCREWS. HE WAS USING THE ZERO-P AIMING DEVICE. HE HAD USED THE ANGLED AWL FOR THE FIRST HOLE AND PLACED THE FIRST SCREW. WHEN ATTEMPTING TO USE THE ANGLED AWL FOR THE REMAINING HOLES SURGEON REMOVED THE AWL FROM THE AIMING DEVICE AND THE TIP OF THE AWL REMAINED IN THE SITU. THE SURGEON THEN REMOVED THE BROKEN TIP FROM THE PATIENT USING A NEEDLE HOLDER. THIS DELAYED THE SURGERY FOR APPROXIMATELY 3-4 MINUTES. THEY HAVE CONTINUED THE PROCEDURE USING THE STRAIGHT AWL. NO ADVERSE EVENT REPORTED. CONCLUSION: DURING MANUFACTURING INVESTIGATION THE HARDNESS OF THE BROKEN AWL TIP AND THE DIAMETER AT THE CROSS SECTION WHERE THE TIP WAS BROKEN HAS BEEN MEASURED. BOTH RESULTS ARE WITHIN SPECIFICATION, IT WAS DETERMINED THAT THE BREAKAGE WAS CAUSED BY MECHANICAL OVERLOADING DURING USE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. THIS COMPLAINT INVOLVES ONE PART. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A C6/7 ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGEON WAS USING THE ANGLED AWL TO BREAK THE CORTEX AND CREATE THE HOLES FOR THE SCREWS. THE SURGEON WAS USING THE ZERO-P AIMING DEVICE AND USED THE ANGLED AWL FOR THE FIRST HOLE, AND PLACED THE FIRST SCREW. WHEN ATTEMPTING TO USE THE ANGLED AWL FOR THE REMAINING HOLES, THE SURGEON REMOVED THE AWL FROM THE AIMING DEVICE AND THE TIP OF THE AWL REMAINED IN THE INSITU. SURGEON THEN REMOVED THE BROKEN TIP FROM THE PATIENT USING A NEEDLE HOLDER. THIS DELAYED THE SURGERY FOR APPROXIMATELY 3-4 MINUTES. THE PROCEDURE CONTINUED, USING THE STRAIGHT AWL. NO ADVERSE EVENT REPORTED. THIS COMPLAINT INVOLVES ONE PART. CONCOMITANT PARTS REPORTED: SCREW PART # UNK, LOT # UNK, QUANTITY 1, ZERO-P AIMING DEVICE PART: 03.617.963 UNK, LOT # UNK QUANTITY 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457747 2.0MM ANGLED AWL APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES HAGENDORF 1966903

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR