BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 8005500 · Received October 25, 2018

    Report

    Report Number
    8030965-2018-57615
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    January 1, 2018
    Report Date
    October 10, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWA
    UDI-DI
    07611819349476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.010.410 , LOT: L021644 , MANUFACTURING SITE: BETTLACH , RELEASE TO WAREHOUSE DATE: 14. JULY 2016 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: WE DID RECEIVE THE IMPACTOR JAMMED TOGETHER WITH THE CORRESPONDING BLADE. BOTH DEVICES HAVE SIGNS OF USE ON THEIR SURFACES. FURTHERMORE WE FOUND THE HANDLE IS BROKEN AT THE WELDED JOINT. THERE ARE ALSO HEAVY HAMMER MARKS VISIBLE ON THE METALLIC PART.THE MICROSCOPIC OBSERVATION SHOWS REMAINING LASER WELDS ON BOTH INVOLVED COMPONENTS SHOWING THAT THE WELD JOINT WAS CORRECT AT THE TIME OF MANUFACTURING. DIMENSIONAL INSPECTION: THE RELEVANT FEATURES CANNOT BE MEASURED AS IT WAS NOT POSSIBLE TO DISASSEMBLE THE PARTS. THIS COMPLAINT CONDITION IS A RESULT FROM INCORRECT HANDLING. DRAWING/SPECIFICATION REVIEW: NOT REQUIRED AS ROOT CAUSE IS USE RELATED. MATERIAL REVIEW/ HARDNESS REVIEW: NOT REQUIRED AS ROOT CAUSE IS USE RELATED. SUMMARY: OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION COULD BE CONFIRMED DUE TO THE JAMMING ISSUE. BASED ON THE RECEIVED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT AS NO DETAILED INFORMATION ABOUT THE EVENT IS AVAILABLE. DUE TO THE HEAVY HAMMERING MARKS WE CAN PRESUME THAT THE INSTRUMENTS WERE SUBJECTED TO AN EXCESSIVE FORCE APPLICATION WHICH MOST LIKELY COULD HAVE CAUSED THE JAMMING AND THE MALFUNCTION OF BOTH DEVICES. NO MANUFACTURING RELATED ISSUES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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. THE DEVICE HAS BEEN 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.

    Description of Event or Problem · 0

    DURING MANUFACTURER¿S PRELIMINARY ANALYSIS OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE IMPACTOR HAS SHOWN THAT THE LASER WELD ON TOP OF THE HANDLE IS BROKEN. THEREFORE THE HANDLE IS SEPARATED FROM THE SHAFT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS AN UNKNOWN DATE IN 2018. 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. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE COULD NOT BE REMOVED FROM THE IMPACTOR. PATIENT STATUS AND PROCEDURE OUTCOME UNKNOWN. THIS REPORT IS FOR AN IMPACTOR FOR PFNA BLADES. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845923 IMPACTOR F/PFNA BLADE IMPACTOR HWA OBERDORF SYNTHES PRODUKTIONS GMBH L021644 07611819349476

    Patients

    Seq Age Sex Outcome Treatment
    1