BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTPL 2 12HO TI

    MDR report key: 8892868 · Received August 14, 2019

    Report

    Report Number
    8030965-2019-67219
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Report Date
    July 17, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819071100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART# 443.091 , LOT# 9875228 , MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 23. MARCH 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RECEIVED PLATE IS SLIGHTLY BENT AS REPORTED. THERE ARE WEAR MARKS AND SCRATCHES VISIBLE ON THE SURFACE OF THE PART. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUMMARY: THE RECEIVED CONDITION OF THE PLATE 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. SINCE THE PLATE SHOWS DAMAGES IN THE AREA WERE THE PLATE IS BENT, WE MUST ASSUME THAT THE PLATE WAS POSSIBLY TRIED TO BEND WITH A PLIERS. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CQ EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. 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 · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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 HUNGARY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING DECONTAMINATION ON AN UNKNOWN DATE, THE PLATE WAS FOUND CURVED. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR AN ADAPTION PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689178 ADAPTPL 2 12HO TI PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 9875228 07611819071100

    Patients

    Seq Age Sex Outcome Treatment
    1