BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING

    MDR report key: 3943272 · Received July 18, 2014

    Report

    Report Number
    3003875359-2014-10209
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    PK112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 PD INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE IS A COMPONENT OF THE ZERO-PROFILE (ZERO-P) ANTERIOR CERVICAL INTERBODY FUSION (ACIF) SYSTEM. THE ZERO-P STAND-ALONE IMPLANTS COMBINE A PREASSEMBLED CERVICAL INTERBODY SPACER WITH AN ANTERIOR CERVICAL PLATE AND ARE DESIGNED TO MINIMIZE CONTACT WITH LOCAL ANATOMICAL STRUCTURE AND PREVENT CONTACT WITH ADJACENT LEVELS. THE ANGLED SCREWDRIVER WITH SLEEVE IS SPECIFICALLY DESIGNED TO BE USED IN CONJUNCTION WITH AN ANGLED AWL FOR HOLE PREPARATION AND SCREW INSERTION IF THE PATIENTS ANATOMY DOES NOT ALLOW USE OF THE STRAIGHT INSTRUMENTS. ALL OTHER SCREW INSERTION DRIVERS ARE INTENDED TO BE UTILIZED WITH A 1.2 NM TORQUE LIMITING ATTACHMENT WHICH IS NOT POSSIBLE WITH THE ANGLED SCREWDRIVER. THE TECHNIQUE GUIDE SPECIFICALLY CAUTIONS: ¿IF THE TORQUE LIMITING ATTACHMENT IS NOT USED, BREAKAGE OF THE DRIVER MAY OCCUR AND COULD POTENTIALLY INCREASE RISK TO THE PATIENT (ZERO-P TECHNIQUE GUIDE J8566-G).THE TOP LEVEL (B)(4) AND ASSOCIATED APPLICABLE DRAWINGS OF AFFECTED COMPONENTS (DISTAL TIP) WERE REVIEWED (B)(4). THE DRAWING WAS FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE DISTAL TIP INVOLVES SEVEN PARTS AND SIX WELDMENTS; (B)(4) REQUIRES A MINIMUM PASSING TORQUE OF 1.8 NM BEFORE ASSEMBLING THE UNIVERSAL JOINT IN (B)(4). THE ANGLED SCREWDRIVER WAS FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. THE PRODUCT WAS RECEIVED UNDER THE COMPLAINT CONDITION ¿TIP BROKEN INTRAOPERATIVELY¿. THE SCREWDRIVER WAS RECEIVED WITH A BROKEN TIP ON THE DISTAL END OF THE DRIVE SHAFT. THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE TORQUE. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE ANGLED SCREWDRIVER WITH SLEEVE WAS NOT DESIGNED TO BE UTILIZED FOR FINAL TIGHTENING OF THE SCREW FOR THE ZERO-P SYSTEM. AT THE TIME OF THE DEVICES MANUFACTURING, THERE WAS NO SUITABLE ALTERNATIVE FOR FINAL TIGHTENING WHEN THE STRAIGHT DRIVER IS UNABLE TO BE UTILIZED BASED ON PATIENT ANATOMY. AS SUCH ANGLED SCREWDRIVER WAS BEING USED IN THE FIELD FOR FINAL TIGHTENING. RECENTLY, AN ANGLED DRIVER WITH A QUICK CONNECT HAS BEEN RELEASED WHICH IS COMPATIBLE WITH A TORQUE LIMITING HANDLE AND ALLOWS PRECISE FINAL TIGHTENING OF THE ZERO-P SCREWS. AS A SUITABLE ALTERNATIVE NOW EXISTS, NO ADDITIONAL TASKS NEED TO BE LAUNCHED TO REVIEW THE PRODUCT DESIGN OR TECHNIQUE GUIDE. THE COMPLAINT IS CONFIRMED, AS THE INSTRUMENT DID FAIL. 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 AN ANGLED STAR DRIVE SCREWDRIVER BROKE INTRA-OPERATIVELY DURING AN INTERIOR CERVICAL FUSION AT C2-3 AND WHILE INSERTING A SCREW, THE TIP OF THE SCREWDRIVER SHEARED AND BROKE OFF. THE SURGEON RETRIEVED THE BROKEN PIECE OF THE SCREWDRIVER AND USED ANOTHER SCREWDRIVER TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A 5 MINUTE DELAY. NO PATIENT HARM WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421468 ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES HAGENDORF 3010806

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR