BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 42MM

    MDR report key: 8778258 · Received July 10, 2019

    Report

    Report Number
    8030965-2019-66147
    Event Type
    Injury
    Date Received
    July 10, 2019
    Report Date
    April 15, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819043152
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 459.420 , LOT: 5945229 , MANUFACTURING SITE: SALZBURG , RELEASE TO WAREHOUSE DATE: 15. FEB. 2018 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE VISUAL INSPECTION OF THE LOCKING BOLT HAS SHOWN THAT THE THREAD ON THE SHAFT IS STRIPPED AND DEFORMED. THE HEXAGONAL RECESS OF THE HEAD HAS SOME MARKS AND DENT VISIBLE. THE BROKEN PART (23MM) OF THE SHAFT IS NOT AVAILABLE FOR AN EVALUATION. DIMENSIONAL INSPECTION WAS PERFORMED. THE MEASURED DIMENSIONS WERE FOUND TO BE WITHIN THE GIVEN SPECIFICATIONS PER THE DRAWINGS REFERENCED ABOVE. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. SUMMARY: THE COMPLAINT IS RATED AS CONFIRMED FOR THIS LOCKING BOLT. WE DO SUPPOSE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES, SUCH AS EXCESSIVE FORCE APPLICATION DURING REMOVAL SURGERY OR A MECHANICAL OVERLOAD SITUATION DURING THE HEALING PROCESS, WHICH FINALLY CAUSED THE POST MANUFACTURING DAMAGES. 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. 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

    ADDITIONAL DEVICE PRODUCT CODES: JDW, JDS, JDN, HTY. (B)(4). 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT FIRST COMPLAINED OF THE LEFT THIGH/HIP PAIN AND ON (B)(6) 2019 PATIENT WAS TOPPLED ON THE BUTTOCKS AREA. THERE WAS A BREAKAGE OF THE IMPLANT. ORIGINALLY, THE PATIENT HAD AN IMPLANTATION OF PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) SYSTEM ON (B)(6) 2018 DUE TO DISLOCATED MULTI-FRACTURE OF THE LEFT FEMUR. SINCE THAT OPERATION THE PATIENT WAS STEADILY BETTER AND STILL UNDER FULL LOAD SYMPTOM-FREE ON THE WALKING FRAME. PATIENT STATUS IS UNKNOWN. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AND OSTEOSYNTHESIS DUE TO THE BROKEN PFNA NAIL AND OSTEOMYELITIS ON (B)(6) 2019. THE PAIN EXPERIENCED BY THE PATIENT IN THE AREA OF THE LEFT UPPER LEG/HIP WAS ATTRIBUTABLE TO THE BROKEN NAIL WHICH HAD OCCURRED WITHOUT SUFFICIENT TRAUMA. THE BROKEN NAIL RESULTED IN MULTIPLE REVISION SURGERIES AND THE DEVELOPMENT OF AN INFECTION AND OF OSTEOMYELITIS. THE BROKEN NAIL WAS REPLACED WITH A LONG PFNA NAIL. THE PATIENT IS STILL IN INPATIENT TREATMENT AFTER COMPLETE REMOVAL OF THE MATERIAL. DEVICE WAS IDENTIFIED AS BROKEN UPON RECEIPT OF THE DEVICE. THIS REPORT IS FOR ONE (1) 4.9MM TI LOCKING BOLT 42MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569446 4.9MM TI LOCKING BOLT 42MM ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 5945229 07611819043152

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention