BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 8976341 · Received September 9, 2019

    Report

    Report Number
    8030965-2019-68115
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Report Date
    June 28, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWA
    UDI-DI
    07611819349476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. THE IMPACTOR WAS RECEIVED WITH THE REPORTED CONDITION OF FUNCTIONAL ISSUES. THE VISUAL INSPECTION CONFIRMED THAT THE CIRCUMFERENTIAL LASER WELD ON TOP OF THE HANDLE IS BROKEN AND THE SHAFT HAS COME LOOSE FROM THE HANDLE. THE INSTRUMENT IS IN USED CONDITION, THERE ARE MARKS OF HAMMER BLOWS VISIBLE. THE COMPLAINT CONDITION IS CONFIRMED AS THE LASER WELD ON TOP OF THE HANDLE IS BROKEN CAUSING THE HANDLE TO DISASSEMBLE. THIS PRODUCTION LOT (2720819) WAS MANUFACTURED IN JUNE 2011 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. FURTHER INVESTIGATION HAS SHOWN THAT THIS IMPACTOR IS PART OF STOP SHIPMENT 2016611, WHICH WAS INITIATED IN APRIL 2016. DUE TO PREVIOUS RECEIVED MARKET FEEDBACK OF THE SAME NATURE A CORRECTIVE AND PREVENTIVE ACTION (CAPA-006556) AS WELL AS A FIELD ACTION (FA #515379 AND HHE-2016-161) WAS INITIATED FOR THIS PART. DESIGN OF PFNA IMPACTOR 03.010.410 CHANGED WITH DCR/DCO #101167. A CORRECTIVE AND/OR PREVENTATIVE ACTION AND A FIELD ACTION ARE ALREADY LAUNCHED. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CQ EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. DEVICE HISTORY LOT PART: 03.010.410, LOT: L924655, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 03. JULY 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MRE FOR UPDATED LOT NUMBER: PART: 03.010.410, LOT: 2720819, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 01 JUNE 2011. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    OCCUPATION: REPORTER IS SYNTHES EMPLOYEE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.010.410. LOT: 2720819. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 01 JUNE 2011. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE IMPACTOR WAS RECEIVED WITH THE REPORTED CONDITION OF FUNCTIONAL ISSUES. THE VISUAL INSPECTION CONFIRMED THAT THE CIRCUMFERENTIAL LASER WELD ON TOP OF THE HANDLE IS BROKEN AND THE SHAFT HAS COME LOOSE FROM THE HANDLE. THE INSTRUMENT IS IN USED CONDITION, THERE ARE MARKS OF HAMMER BLOWS VISIBLE. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE LASER WELD ON TOP OF THE HANDLE IS BROKEN CAUSING THE HANDLE TO DISASSEMBLE. THIS PRODUCTION LOT (2720819) WAS MANUFACTURED IN JUNE 2011 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. FURTHER INVESTIGATION HAS SHOWN THAT THIS IMPACTOR IS PART OF STOP SHIPMENT (B)(4), WHICH WAS INITIATED IN APRIL 2016. DUE TO PREVIOUS RECEIVED MARKET FEEDBACK OF THE SAME NATURE A CORRECTIVE AND PREVENTIVE ACTION AS WELL AS A FIELD ACTION WAS INITIATED FOR THIS PART. DESIGN OF PFNA IMPACTOR 03.010.410 CHANGED WITH DCR/DCO (B)(4). 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HOSPITAL SENT THE DEFECTIVE DEVICE BACK TO (B)(6). NO PATIENT HARM NOR SURGICAL DELAY REPORTED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE CIRCUMFERENTIAL LASER WELD ON TOP OF THE HANDLE IS BROKEN AND THE SHAFT HAS COME LOOSE FROM THE HANDLE. THIS DEVICE CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON AUGUST 13, 2019. THIS REPORT IS FOR ONE (1) IMPACTOR F/PFNA BLADE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771000 IMPACTOR F/PFNA BLADE IMPACTOR HWA OBERDORF SYNTHES PRODUKTIONS GMBH 2720819 07611819349476

    Patients

    Seq Age Sex Outcome Treatment
    1