BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S

    MDR report key: 5577479 · Received April 14, 2016

    Report

    Report Number
    3000270450-2016-10094
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Report Date
    March 15, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF RECEIVED, A FOLLOW UP REPORT AND/OR ADDITIONAL RELATED COMPLAINTS WILL BE OPENED AND REPORTED AS APPROPRIATE. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. MULTIPLE UNKNOWN EVENT DATES. OTHER NUMBER¿UDI: (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. REPORTING FACILITY PHONE NUMBER IS (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WILL BE REQUESTED FOR THE SUBJECT DEVICE LOT. 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

    MANUFACTURING DATE: JANUARY 18, 2016. MANUFACTURING LOCATION: (B)(4) (INCOMING INSPECTION AND RELEASE, MANUFACTURED BY (B)(4), STERILIZED BY (B)(4)). BUSINESS GROUP: POWER TOOLS. DEVICE PART 03.000.424S, LOT 0864688 IS A BATCH NUMBER CONTROLLED PRODUCT, THEREFORE NO SERVICE HISTORY RECORD REVIEW IS POSSIBLE. NO NON-CONFORMANCE REPORTS, REWORK OR OTHER RELEVANT QUALITY NOTIFICATIONS WERE REFERENCED IN THE DEVICE HISTORY RECORD. 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. THE CONCLUSION OF THE DHR REVIEW IS THAT THE FINAL PRODUCT, MET INSPECTION REQUIREMENTS, CERTIFICATION TEST VALUES, AND ACCEPTANCE CRITERIA. 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 MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED WITH THE SAW BROKEN AROUND THE CONNECTING THREAD. SIGNS OF IMPROPER USE CAN BE OBSERVED. THERE ARE SLIGHT DAMAGES TO THE SAW TEETH AND THE BOW BUT MOST IMPORTANT ARE THE CIRCULAR FRACTURES AROUND THE COUPLING THREAD. NO TEMPER COLORS CAN BE SEEN. THAT INDICATES THAT THE BREAKAGE MIGHT BE DUE TO EXCESSIVE MECHANICAL STRESS BUT NOT NECESSARILY DUE TO OVERHEATING. MOST LIKELY THE SAW BLADES BROKE DUE TO EXCESSIVE MECHANICAL STRESS APPLIED. THERE IS NO CLEAR EVIDENCE WHETHER THIS MECHANICAL STRESS WAS APPLIED DURING SURGERY OR WHETHER THE SAW BLADES WERE DAMAGED ALREADY BEFORE DURING COUPLING TO THE HAND PIECE. A SPECIAL TORQUE LIMITER KEY HAS TO BE USED FOR COUPLING THE SAW BLADES TO THE HAND PIECE IN ORDER TO AVOID TOO HIGH TORQUE BEING APPLIED. THE MOST PROBABLE ROOT CAUSES HAVE TO BE CONSIDERED AS IMPROPER HANDLING BY CUSTOMER. 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: 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING UNKNOWN PROCEDURES ON MULTIPLE UNKNOWN DATES, FOUR PIEZOELECTRIC SYSTEM SAWBLADES BROKE. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232125 SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNTHES SELZACH 0864688

    Patients

    Seq Age Sex Outcome Treatment
    1