BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    MDR report key: 5514207 · Received March 21, 2016

    Report

    Report Number
    3003875359-2016-10190
    Event Type
    Malfunction
    Date Received
    March 21, 2016
    Date of Event
    March 4, 2016
    Report Date
    March 4, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. S&R SERVICE HISTORY REVIEW WAS ATTEMPTED: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 03.010.473 WITH LOT NUMBER(S) 7854069 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 6-APR-2012. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 03.APR.2012, 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

    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: A PRODUCT INVESTIGATION WAS COMPLETED: THE TITANIUM CANNULATED TIBIAL NAILS TECHNIQUE GUIDE, THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL TECHNIQUE GUIDE, AND THE TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) TECHNIQUE GUIDE WERE REVIEWED DURING THE INVESTIGATION AND FOUND TO ADDRESS RECOMMENDED USAGE. THE SCREWDRIVER WAS RECEIVED DISASSEMBLED WITH ALL COMPONENTS INTACT. THE DISTAL TIP OF THE MAIN BODY IS TWISTED AXIALLY IN THE DIRECTION OF SCREW INSERTION. THE SLIDING BAR IS ONLY DEFORMED ON THE DISTAL EDGE AND DOES NOT SHOW TWISTING. THEREFORE, THE SLIDING BAR NO LONGER PROPERLY MATES WITH THE MAIN BODY OF THE SCREWDRIVER TO ENGAGE THE SCREW. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT IS INCONSISTENT WITH THE REPORTED CONDITION AS THE DEVICE IS TWISTED NOT BROKEN. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY DEFORMED. A REVIEW OF THE RELEVANT DRAWINGS FOR EACH DEVICE WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE RECEIVED CONDITION IS CONSISTENT WITH THE RESULT OF TORSION BEYOND THE PLASTIC DEFORMATION LIMIT OF THE MAIN BODY OF THE SCREWDRIVER. THE UNTWISTED CONDITION OF THE SLIDING BAR SHOWS EVIDENCE THAT THE SLIDING BAR WAS NOT FULLY ADVANCED WHEN THE DEFORMATION OCCURRED. PER THE TECHNIQUE GUIDE, THE SLIDING BAR TIP IS TO BE FULLY WEDGED INTO THE SCREW HEAD RECESS PRIOR TO USE AND THE USER IS TO ALWAYS USE THE STANDARD SCREWDRIVER FOR FINAL TIGHTENING OF THE SCREW. HOWEVER, AS THE USER TECHNIQUE AND THE CONDITIONS AT THE TIME OF THE DAMAGE ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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 BILATERAL RETROGRADE NAILS, THE SCREWDRIVER TIP BROKE OFF, BUT NOT IN THE PATIENT. SURGEON DID NOT USE A BACK-UP PART AND COMPLETED SURGERY WITHOUT IT. SURGERY WAS COMPLETED WITHOUT ANY ADDITIONAL ISSUES. NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170654 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX SYNTHES HAGENDORF 7854069

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR