BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT/LONG FOR TRAUMA RECON SYSTEM

    MDR report key: 4131184 · Received October 1, 2014

    Report

    Report Number
    3009450871-2014-10437
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: SAW ATTACHMENT 05.001.224 SERIAL NUMBER: (B)(4) WAS RECEIVED IN SLIGHTLY USED OPTICAL CONDITION. ALL TESTING WAS PERFORMED ACCORDING TO CHAPTER PRE-REPAIR DIAGNOSTIC ASSESSMENT/INCOMING INSPECTION OF THE SERVICE MANUAL. THE ATTACHMENT PASSED ALL TESTING; NO FAILURE COULD BE IDENTIFIED. THE COMPLAINT CONDITION WAS TESTED IN WORST CASE CONDITIONS (SAW BLADE 05.002.105 IN WOOD). ADDITIONALLY THE COMPLAINT CONDITION WAS TESTED WITH MALE AND FEMALE USERS, THE SAW BLADE LOOSENING ONLY OCCURRED WHEN THE CLAMPING SCREW WAS NOT TIGHTENED ACCORDING TO INSTRUCTIONS FOR USE HARD ENOUGH WITH DEDICATED T-HANDLE 05.001.229. AS A REFERENCE VALUE A MINIMUM FIXATION TORQUE OF 5NM WAS EXPERIENCED, WHICH WAS POSSIBLE TO BE OPERATED BY FEMALE PROBANDS. REVIEW OF PRODUCTION HISTORY REVEALED THAT ALL INVESTIGATED INSTRUMENTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE ALLEGED "SAW BLADE HAS LOOSENED DURING SURGERY" REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED WHEN THE ATTACHMENT WAS USED ACCORDING TO INSTRUCTIONS FOR USE. ACCORDING TO INSTRUCTIONS FOR USE: SAW ATTACHMENT 05.001.224 MUST ALWAYS BE USED IN SAW MODE (80% LESS POWER OUTPUT OF THE POWER MODULE). THE SAW BLADE MUST BE TIGHTENED HARD (TURNING THE SCREW-CLAMPING-MECHANISM TO THE END) AND DOUBLE-CHECKED BEFORE USAGE. ONLY ORIGINAL SYNTHES SAW BLADES ARE RECOMMENDED. IT IS ALSO RECOMMENDED TO REPLACE CLAMPING SCREW DUE TO SHARP EDGES AND REPLACE OSCILLATING HEAD, THE LOOSENED SAW BLADE CAUSED ABNORMAL WEAR. ALL SAW ATTACHMENTS FOR TRAUMA RECON SYSTEM BATTERY MODULAR NEED ALWAYS TO BE OPERATED IN SAW MODE, THE MODE SWITCH IS INTEGRATED IN THE LID OF THE HAND-PIECE. 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SAW BLADE HAS LOOSENED DURING SURGERY. NO PROLONGATION OF SURGERY WAS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612708 SAGITTAL SAW ATTACHMENT/LONG FOR TRAUMA RECON SYSTEM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1