BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5267179 · Received December 4, 2015

    Report

    Report Number
    3000270450-2015-10241
    Event Type
    Malfunction
    Date Received
    December 4, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 11, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    DZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THE AS RECEIVED CONDITION FOUND THAT THE SAW OF THE PIEZO ELECTRIC SYSTEM WAS BROKEN. THE MACROSCOPIC ASSESSMENT SHOWED MECHANICAL DAMAGE ON THE SAW TEETH AS WELL AS ON THE BOW OF THE SAW. FURTHER THERE WERE TEMPER COLORS VISIBLE INSIDE THE CONTACT HOUSING. THE FRACTURE FACE SHOWED SEVERAL ¿CHEVRON-LINES¿ FROM THE INSIDE OF THE HOUSING TOWARDS OUTSIDE WHICH ARE AN INDICATION FOR THE PATH OF CRACK. THE INVESTIGATION OF THE FRACTURE FACE INSIDE THE SCANNING ELECTRON MICROSCOPE (SEM) REVEALED HEAVY THERMO-MECHANICAL DAMAGE OF THE INNER SURFACE OF THE CONTACT HOUSING, INCLUDING THE THREAD AND SECTIONS OF THE FRACTURE SURFACE. THE FRACTURE SURFACE SHOWED EVERYWHERE HEAT AFFECTED APPEARANCE AND THERE WERE ONLY FEW SIGNS OF FATIGUE FRACTURE STRUCTURES FOUND, SUCH AS COARSE AND FINE SECONDARY CRACKS AS WELL AS FINE BUT DISCERNIBLE FATIGUE STRIATIONS. THE CAUSE OF DAMAGE IS ACCORDING TO THE ABOVE MENTIONED FACTS, A COMBINATION OF THERMAL AND MECHANICAL DAMAGE OF THE INNER SURFACE/THREAD OF THE CONTACT HOUSING DUE TO OVERHEATING THE INSTRUMENT BY APPLYING TO INADEQUATE HIGH MECHANICAL LOAD. 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 PRODUCT CODES: ERL, HBE, HWE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. MANUFACTURING DATE: 10 AUGUST 2015. MANUFACTURING LOCATION: (B)(4). DEVICE 03.000.424S, LOT 861246 IS A BATCH NUMBER CONTROLLED PRODUCT, THEREFORE NO SERVICE HISTORY RECORD REVIEW IS POSSIBLE. DEVICE HISTORY RECORD REVIEW RESULT BELOW: DEVICE MANUFACTURED BY (B)(4), DELIVERED TO AND RELEASED FOR DISTRIBUTION IN (B)(4). 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 RECORDS, CERTIFICATION TEST VALUES, AND ACCEPTANCE CRITERIA. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A MANDIBULAR SURGERY THE SAWBLADE BROKE. IT WAS REPORTED THERE WAS NO PATIENT HARM AND NO DELAY. THE BROKEN PARTS WERE ALL FOUND AND RETRIEVED; NONE WERE LEFT IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION NECESSARY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796746 SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S DRILL, BONE, POWERED DZI SYNTHES SELZACH 0861246

    Patients

    Seq Age Sex Outcome Treatment
    1