BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS

    MDR report key: 4599740 · Received March 13, 2015

    Report

    Report Number
    3003875359-2015-10144
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 2, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    A PRODUCT INVESTIGATION WAS COMPLETED: TWO SELF-RETAINING SCREWDRIVERS FOR CSLP QUICK LOCK (PART 03.610.602, LOT 9063381 MANUFACTURED OCTOBER 16, 2014, AND LOT 8899652 MANUFACTURED MAY 16, 2014), ONE TI CERVICAL SPINE LOCKING PLATE(PART 450.172, LOT 9285471, MANUFACTURED DECEMBER 2014), AND FOUR 4.5MM TITANIUM QUICK LOCK CANCELLOUS SCREWS, SELF-DRILLING (TWO OF PART 04.610.118 AND TWO OF PART 04.610.120) WERE RETURNED. UPON RECEIPT OF THESE DEVICES IT WAS SEEN THAT TWO OF THE FLANGES OF SCREWDRIVER LOT 9063381 ARE BROKEN OFF, AND ONE OF THE FLANGES OF SCREWDRIVER 8899652 IS BROKEN OFF. ONE SCREW (PART 04.610.120) HAS THE HEAD OF THE SCREW BROKEN OFF, BUT THE INNER LOCKING SCREW STILL RETAINED. THE OTHER SCREWS HAVE SIGNS OF WEAR WHICH ARE CONSISTENT WITH INSERTION AND REMOVAL, THE RETURNED PLATE HAS MINOR SCRATCHES, AND THE HOLES OF THE PLATE CONFORM DIMENSIONALLY. THIS COMPLAINT IS CONFIRMED. IT IS UNKNOWN WHAT LED TO THIS COMPLAINT CONDITION, THE HEADS OF THE SCREWS ARE NO LONGER IN THE SAME CONDITION AS THEY WOULD HAVE BEEN DURING INSERTION DO TO THE FORCES EXERTED DURING INSERTION AND REMOVAL AND THE HOLES OF THE PLATE CONFORM TO THE DRAWING. OVER INSERTION OF THE SCREWS MAY HAVE LED TO THE SCREWS GOING THROUGH THE PLATE, AND IT IS UNKNOWN IF THE LOCKING SCREWS WERE ALL UNLOCKED PRIOR TO THE SCREWS BEING REMOVED GIVEN THE VARIED LOCKING STATES OF THE RETURNED SCREWS. IF THE LOCKING SCREWS WERE NOT LOOSENED PRIOR TO REMOVAL THAT WOULD HAVE REQUIRED ADDITIONAL FORCE ON THE SCREWDRIVERS TO REMOVE THESE SCREWS ¿ LEADING TO THE BROKEN FLANGES OF THE SELF-RETAINING SCREWDRIVERS. THE DRAWINGS WERE REVIEWED AND THE DESIGNS, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE ADEQUATE FOR THE INTENDED USES OF THESE DEVICES. THE COMPLAINT HISTORIES WERE REVIEWED; AS WAS RISK DOCUMENTATION AND THE HARMS AND HAZARDS ARE ADDRESSED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ISSUES RELATING TO MANUFACTURING WERE FOUND WHICH WOULD RESULT IN 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE DOCTOR WAS PLACING THE CERVICAL SPINE LOCKING PLATE (CSLP) QUICK LOCK 18MM SCREWS IN CSLP PLATE AND THE SCREW ADVANCED THROUGH THE SCREW HOLE ON THE PLATE WITHOUT STOPPING. THE DOCTOR TRIED TO BACK UP THE SCREW AND THE SCREW BROKE. HE THEN DECIDED TO REMOVE THE OTHER SCREWS AND TAKE OFF THE PLATE TO RETRIEVE THE BROKEN SCREW. HE THEN REALIZED ANOTHER SCREW HAD GONE THROUGH THE PLATE AND WHILE TRYING TO BACK IT OUT, BROKE THE TIP OFF OF TWO SCREWDRIVERS. SCREWDRIVER TIPS WERE RETRIEVED. DURING THE THIRD ATTEMPT, HE WAS ABLE TO BACK THE SCREW OUT AND RETRIEVE THE ORIGINAL BROKEN SCREW. HE THEN USED A SHORTER PLATE AND COMPLETED SURGERY. ALL SCREW PARTS WERE RETRIEVED. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THIS IS REPORT 4 OF 5 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175354 SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS SCREWDRIVERS HXX SYNTHES HAGENDORF 9063381

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention