BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR ANGLED SCREWDRIVER

    MDR report key: 4835910 · Received June 10, 2015

    Report

    Report Number
    3003875359-2015-10266
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 25, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    PK112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW -- 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

    (B)(6). PRODUCT INVESTIGATION SUMMARY: THREE DRIVERS (PART 03.617.905) WERE RECEIVED WITH A FRACTURED TIP AT THE LASER WELD. ALL THREE DRIVERS ARE FROM THE SAME LOT 9242042, WHICH WAS MANUFACTURED ON NOVEMBER 25, 2014. TWO OF THE DRIVERS WERE RECEIVED WITH THE LIBERATED FRAGMENT MISSING. ONE DRIVER HAS A FRACTURE 360 DEGREES AROUND THE LASER WELD WITH THE DRIVER TIP STILL INTACT WITH THE UNIVERSAL JOINT. AS THE TIPS BROKE AT THE WELD, THIS IMPLIES THAT THE END USER MAY HAVE NOT USED THE 1.2 N-M TORQUE LIMITING ATTACHMENT, WHICH IS REQUIRED FOR FINAL TIGHTENING (PER THE SURGICAL TECHNIQUE). 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. PART 03.617.905 IS ONE DRIVER OUT OF MULTIPLE OPTIONS FOR INSERTING AND FINAL TIGHTENING OF ZERO-P SCREWS. THE DEVICE ALLOWS FOR INSERTION AT DIFFICULT ANGLES DUE TO THE PATIENT ANATOMY (TYPICALLY MORE CRANIAL OR CAUDIAL CERVICAL DISC LEVELS). THE ENGINEER REVIEWED THE ASSOCIATED DRAWINGS. DRAWINGS SPECIFY A FUNCTIONAL LASER WELD WITH FILLER MATERIAL WITH A MINIMUM TORQUE REQUIREMENT OF 2+/-0.2 N-M. AS THE TIPS BROKE AT THE WELD, THIS IMPLIES THAT THE END USER MAY HAVE NOT USED THE 1.2 N-M TORQUE LIMITING ATTACHMENT WHICH IS REQUIRED FOR FINAL TIGHTENING PER THE SURGICAL TECHNIQUE. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE AWARENESS DATE IN THE FIRST FOLLOW UP MEDWATCH WAS REPORTED IN ERROR AS JUNE 19, 2015. THE CORRECT AWARENESS DATE FOR PART RETURN (AND THEREFORE THAT REPORT) WAS JUNE 16, 2015. DEVICE IS 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

    PER LAST FOLLOW UP, THE INITIALLY REPORTED LOT # 9242042 WAS CHANGED TO LOT # 8669184. IT WAS CONFIRMED THAT THE INITIALLY REPORTED LOT # WAS INDEED CORRECT. THEREFORE INITIALLY REPORTED DHR WAS ALSO CORRECT. 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

    PER PRODUCT HANDLERS - LOT # 9242042 HAS BEEN CHANGED TO LOT # 8669184. A NEW DHR WILL BE LAUNCHED FOR THIS INSTRUMENT, THEREFORE, THIS DHR IS FOR THE REPORTED LOT #9242042, WHEN NEW DHR INFORMATION IS OBTAINED, MW WILL BE UPDATED ACCORDINGLY. 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. (B)(4), MANUFACTURING DATE: 25.NOV.2014, 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY FOR AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C5-C7 LEVEL, DURING THE FINAL TIGHTENING OF THE SCREW AT THE C7 LEVEL THE SCREW-DRIVER TIP BROKE OFF. SURGEON CHOSE TWO MORE SCREW-DRIVERS AND THE TIP BROKE OFF ON THESE INSTRUMENT ALSO. SURGEON USED ANOTHER SCREW DRIVER AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL TIME ADDED AND NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380490 INNER SHAFT FOR ANGLED SCREWDRIVER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES HAGENDORF 9242042

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR