BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL

    MDR report key: 10014270 · Received April 30, 2020

    Report

    Report Number
    8030965-2020-03220
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 14, 2020
    Report Date
    April 14, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTC
    UDI-DI
    07611819690721
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART NUMBER: 03.130.270, LOT NUMBER: T131833, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: MARCH 2, 2016. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. VISUAL INSPECTION: THE DEVICE WAS DELIVERED IN ONE SEALABLE BAG. THE DEVICE APPEARS TO BE IN A GOOD CONDITION BEFORE THE HEAD OF THE CUTTING PLIERS BROKE OFF ON ONE SIDE. SOME OF THE WELD PROTECTION POINTS ARE BROKEN. FUNCTIONAL TEST: FUNCTIONAL TEST CANNOT BE PERFORMED, IT CAN BE CONFIRMED THAT THE DEVICE IS BROKEN. DIMENSIONAL INSPECTION: THE RELEVANT FEATURES MEASURED ARE WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURED AND CURRENT REVISIONS OF THE DRAWING WERE REVIEWED, AND NO RELEVANT DESIGN CHANGES WERE IDENTIFIED. THE REVIEW OF THE MANUFACTURING RECORDS CONFIRM THAT THE USED MATERIAL (1.4112) AND THE HARDNESS (53-56 HRC) DURING THE PRODUCTION WERE ACCORDING TO THE SPECIFICATION OF THE DEVICE. THE MEASURED HARDNESS WAS 54,6 - 54,8 HRC. SUMMARY: THE RECEIVED CONDITION OF THE INLINE PLATE CUTTER IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THIS LOT WAS MANUFACTURED IN MARCH 2016 ACCORDING TO THE SPECIFICATION. BASED ON THAT AND THE CONDITION OF THE ITEM A PRODUCT RELATED ISSUE CAN BE EXCLUDED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE BREAKAGE OCCURRED IS DETERMINED TO BE POSTPRODUCTION CRITERIA¿S. UNFORTUNATELY, THE EXACT CAUSE WHICH HAS LED TO THE BREAKAGE COULD NOT BE EVALUATED, THE INLINE PLATE CUTTER IS PROBABLY BROKEN DUE TO A MECHANICAL OVERLOAD SITUATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A SURGERY FOR THE SECOND, THIRD AND FOURTH METACARPAL BONE FRACTURES. DURING THE PLATE CUT, THE CUTTING PLIERS BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477562 PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL PLIERS,SURGICAL HTC OBERDORF SYNTHES PRODUKTIONS GMBH T131833 07611819690721

    Patients

    Seq Age Sex Outcome Treatment
    1