BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET

    MDR report key: 8736421 · Received June 26, 2019

    Report

    Report Number
    8030965-2019-65774
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Report Date
    May 30, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTD
    UDI-DI
    07611819220997
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: E1 H3, H4, H6: PART 399.097, LOT 5934895: MANUFACTURING SITE: SALZBURG. RELEASE TO WAREHOUSE DATE: JUNE 03, 2015. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE LOCKING MECHANISM AT THE FORCEPS IS DAMAGED, AS A PIECE IS BROKEN OFF, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. DURING INVESTIGATION A FUNCTIONAL TEST WAS PERFORMED. THE FORCEPS FAILED THE FUNCTIONAL TEST, BASED ON THE ALREADY MENTIONED DAMAGE (BROKEN OF PIECE) THE LOCKING MECHANISM DOES NOT FUNCTION AS INTENDED ANYMORE. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. THE RELEVANT DRAWINGS AND TECHNIQUE GUIDE WAS PERFORMED. FURTHERMORE, THE REPORTED DEVICE WAS ASSEMBLED ACCORDING TO DRAWING, AND ALL PARTS WENT THROUGH A 100% FUNCTIONAL TEST, BEFORE THEY HAD LEFT THE PRODUCTION. IN ADDITION, THE REVIEW HAS SHOWN THAT THE HARDNESS WAS WITHIN THE SPECIFICATION. THERE IS NO PARTICULARIZE INFORMATION WHAT'S HAPPENED TO THIS ARTICLE BY CUSTOMER, UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE ASSUME THAT HIGH APPLIED MECHANICAL FORCE COULD HAVE LED TO THIS DAMAGE OR/AND THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: REPORTER IS J&J EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING TOMOFIX PROCEDURE, A BONE SPREADER WAS FOUND TO BE WORN OUT. A NEW BONE SPREADER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND WAS NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528545 BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET FORCEPS HTD OBERDORF SYNTHES PRODUKTIONS GMBH 5934895 07611819220997

    Patients

    Seq Age Sex Outcome Treatment
    1