BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP DIST-FEMPL4.5/5 R 17HO L396 SST

    MDR report key: 9490778 · Received December 18, 2019

    Report

    Report Number
    8030965-2019-70967
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    August 23, 2019
    Report Date
    November 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819304116
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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, 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 · 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. SELECTED FLOW: DAMAGE. VISUAL INSPECTION: THE PLATE WAS FOUND CRACKED AT THE 9TH HOLE, COUNTED FROM THE END SIDE. FURTHERMORE, THERE ARE SEVERAL MECHANICAL DAMAGES VISIBLE ON THE SURFACE. DIMENSIONAL INSPECTION: A DIMENSIONAL TEST IS NOT POSSIBLE, AS THE PART GOT LOST DURING SHIPMENT TO MANUFACTURING SITE. THIS SHIPMENT ISSUE IS CURRENTLY ADDRESSED THROUGH THE NR-0140302 AS DIRECT ACTION TO THIS COMPLAINT TO INVESTIGATE SUCH AN OCCURRENCE AND AVOID IT IN THE FUTURE. DRAWING/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. FURTHERMORE, AS INDICATED IN THE MANUFACTURING DOCUMENTS, THE CORRECT MATERIAL WAS USED ACCORDING ISO. SUMMARY THE RECEIVED PART AND THE ATTACHED PICTURES DOES CONFIRM THAT THE PART IS CRACKED AND NOT BROKEN, AS THE PART DID NOT SEPARATE INTO 2 OR MORE PIECES. NEVERTHELESS, THIS COMPLAINT WILL BE RATED AS CONFIRMED DUE TO THE DAMAGE INCURRED. BASED ON THE FINDINGS ABOVE A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. THIS LOT OF 4 PIECES WAS MANUFACTURED IN APRIL 2018, ALL DEVICES ARE DISTRIBUTED AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT NUMBER COMBINATION. THIS AND THE FINDINGS ABOVE LET US EXCLUDE A MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, MAL-UNION, OVERLOADING OF THE OSTEOSYNTHESIS OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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,PRE INVESTIGATION STATEMENT: ONLY MANUFACTURING INVESTIGATION WILL BE DOCUMENTED IN THIS PI, AS ALL OTHER INVESTIGATION STEPS ARE COVERED UNDER PI-(B)(4). INVESTIGATION SITE: MEZZOVICO. SELECTED FLOW: DAMAGE. SUMMARY MANUFACTURING INVESTIGATION: - RETURNED ITEM HAS NOT BEEN RECEIVED IN ORIGINAL PACKAGING. INFORMATION ETCHED ON IT MATCHES TO COMPLAINT SYSTEM AND DHR. ITEM IS VISUALLY BENT AND BROKEN POST PRODUCTION AT LEVEL OF THE HOLE NUMBER 9. NO EVIDENCE OF VISUAL NON-CONFORMANCE MANUFACTURING RELATED. THE RETURNED ITEM HAS BEEN MANUFACTURED AND THEN RELEASED IN APRIL 2018 ACCORDING DRAWING VALID FROM NOV. 10, 2010 TO DEC. 20, 2018. NO NON-CONFORMANCES OR DOCUMENT CHANGE HAVE BEEN IDENTIFIED WHICH MAY BE RELATED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS REINSPECTED FOR ALL THE FEATURES RELEVANT TO THE COMPLAINT CONDITION. THE MEASURABLE FEATURES HAVE BEEN FOUND CONFORMING THE INVOLVED LOT HAS BEEN MANUFACTURED STARTING FROM THE RAW MATERIAL ART 60051390/LOT L459046. IN THE CERTIFICATE FOR RAW MATERIAL OF THE LOT L459046 IT¿S STATED THAT THE MATERIAL IS CONFORMING TO SPECIFICATION. AS PER SELECTED INVESTIGATION FLOW FROM W-M-S080 APPENDIX A, THE INVESTIGATIONS PERFORMED DIDN'T IDENTIFY ANY MANUFACTURING DEFECT OR DEFICIENCY, THUS THE COMPLAINT INVESTIGATION IS CONSIDERED AS NOT MANUFACTURING RELATED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. PART NUMBER: 02.124.034S, SYNTHES LOT NUMBER: L816409, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: APRIL 05, 2018, EXPIRY DATE: MARCH 01, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.,PART NUMBER: 02.124.034S, SYNTHES LOT NUMBER: L816409, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: APRIL 05, 2018, EXPIRY DATE: MARCH 01, 2028. 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 · 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: PART 02.124.034S, LOT L816409: MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: APRIL 05, 2018. EXPIRY DATE: MARCH 01, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: THE PLATE WAS FOUND CRACKED AT THE NINTH HOLE, COUNTED FROM THE END SIDE. FURTHERMORE, THERE ARE SEVERAL MECHANICAL DAMAGES VISIBLE ON THE SURFACE. 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. FURTHERMORE, AS INDICATED IN THE MANUFACTURING DOCUMENTS, THE CORRECT MATERIAL WAS USED ACCORDING SPECIFICATIONS. THE RECEIVED PART AND PICTURES CONFIRM THAT THE PART IS CRACKED AND NOT BROKEN, AS THE PART DID NOT SEPARATE INTO TWO (2) OR MORE PIECES. NEVERTHELESS, THIS COMPLAINT WILL BE RATED AS CONFIRMED DUE TO THE DAMAGE INCURRED. BASED ON THE FINDINGS ABOVE A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. IT IS LIKELY THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, MAL-UNION, OVERLOADING OF THE OSTEOSYNTHESIS OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H11: CORRECTED DATA: B3: EXACT DATE THE PLATE BROKEN IS UNKNOWN; REPORTEDLY IT BROKE SOMETIME IN 2019. 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

    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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, ON (B)(6) 2019 OF A MEDICAL DEVICE REMOVAL SURGERY FOR A BROKEN LCP DIST-FEMPL4.5/5 R 17HO L396 SST. OUTCOME OF THE PROCEDURE IS UNKNOWN. NO OTHER INFORMATION AVAILABLE AT THIS TIME. CONCOMITANT DEVICE REPORTED: UNK - SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 7). UNK - CABLE/WIRE: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284001 LCP DIST-FEMPL4.5/5 R 17HO L396 SST PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L816409 07611819304116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - CABLE/WIRE| UNK - SCREWS: TRAUMA