BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING

    MDR report key: 4668256 · Received April 8, 2015

    Report

    Report Number
    1719045-2015-10218
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 23, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    PK112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. PRODUCT INVESTIGATION SUMMARY: THE ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE (PART 03.617.900, LOT 1944160) WAS RECEIVED WITH A BROKEN TIP ON THE DISTAL END OF THE DRIVE SHAFT. ADDITIONALLY, THE SLEEVE IS UNABLE TO PASS OVER THE DRIVE SHAFT¿S UNIVERSAL JOINT FOR REASSEMBLY. BOTH FAILURE MODES ARE CONSISTENT WITH THE APPLICATION OF EXCESSIVE TORQUE. REPLICATION OF THE RETURNED DEVICE IS NOT APPLICABLE SINCE THE PART WAS RETURNED BROKEN. THE RETURNED CONDITION AGREES WITH THE COMPLAINT DESCRIPTION AND SO THE COMPLAINT IS DEEMED CONFIRMED. THE DRIVER IS A COMPONENT OF THE ZERO-PROFILE (ZERO-P) ANTERIOR CERVICAL INTERBODY FUSION (ACIF) SYSTEM AND IS DESIGNED TO BE USED IN CONJUNCTION WITH AN ANGLED AWL FOR HOLE PREPARATION AND SCREW INSERTION IF THE PATIENT¿S ANATOMY DOES NOT ALLOW USE OF THE STRAIGHT INSTRUMENTS. FOR FINAL TIGHTENING, ONLY DRIVERS COMPATIBLE WITH A 1.2 NM TORQUE LIMITING ATTACHMENT (03.110.002.99) SHOULD BE USED. 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.¿ THIS COMPLAINT IS CONSISTENT WITH THE FAILURE DUE TO TORQUE. BENCH TOP TESTING ESTABLISHED THE FAILURE TORQUE OF THE ANGLED DRIVER TO BE 2.45 NM +/- 0.63 NM, WHICH EXCEEDS THE TORQUE NECESSARY TO ENGAGE THE LOCKING MECHANISM OF THE SCREWS. BECAUSE THE DRIVER FAILED INTRA-OPERATIVELY, IT IS LIKELY THE DRIVER WAS BEING USED FOR FINAL TIGHTENING AND A TORQUE GREATER THAN THE 1.2 NM REQUIRED FOR LOCKING WAS BEING APPLIED. THE ANGLED DRIVER IS NOT DESIGNED OR INTENDED TO BE USED FOR FINAL TIGHTENING OF THE SCREWS TO ENGAGE THE TAPER LOCKING MECHANISM. A SHAFT FOR ANGLED SCREWDRIVER WITH QUICK COUPLING (03.617.905) AND TORQUE LIMITING HANDLE (03.110.002.99) CAN BE UTILIZED FOR ANGLED FINAL TIGHTENING OF THE SCREWS WHEN THE PATIENT ANATOMY DOES NOT ALLOW FOR USE OF THE STRAIGHT INSTRUMENTS. THE ANGLED DRIVER WAS LIKELY USED FOR FINAL TIGHTENING. FINAL TIGHTENING SHOULD BE PERFORMED WITH A DRIVER COMPATIBLE WITH THE TORQUE LIMITER. WITHOUT A TORQUE LIMITER, EXCESSIVE TORQUE COULD BE APPLIED TO THE DRIVER AND CAUSE IT TO BREAK. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE PARTS WERE ACCEPTED AT THE SYNTHES (B)(4) PURCHASE OPERATION. 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

    (B)(4). 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING SITE: (B)(4); MANUFACTURING DATE: 07. AUG. 2008, NO NCRS 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. 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 THE PROCEDURE, THE SURGEON HAD SUCCESSFULLY PLACED THE ZERO-P IMPLANT AND THREE SCREWS. WHILE TRYING TO IMPLANT THE FOURTH SCREW, HE NEEDED TO USE THE ANGLED STARDRIVE SCREWDRIVER. WHILE INSERTING THE SCREW, THE JOINT ON THE ANGLED DRIVER SNAPPED INSIDE THE PATIENT. THE SURGEON REMOVED THE BROKEN DRIVER WITH SLEEVE AND WAS ABLE TO RETRIEVE THE DRIVER TIP WITHOUT ISSUE. THIS CAUSED NO HARM TO THE PATIENT, JUST A DELAY OF TWO TO THREE MINUTES IN THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231171 ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES HAGENDORF 1944160

    Patients

    Seq Age Sex Outcome Treatment
    1