BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 50MM

    MDR report key: 8960508 · Received September 4, 2019

    Report

    Report Number
    8030965-2019-67963
    Event Type
    Injury
    Date Received
    September 4, 2019
    Report Date
    September 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTY
    UDI-DI
    07611819043190
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: JDW, JDS, JDN, HSB. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 459.500. LOT: 5942370. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 14. MAR. 2017. 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: A PIECE OF ABOUT 25MM LENGTH IS BROKEN OFF FROM THE RECEIVED LOCKING BOLT. THE FRAGMENT WAS NOT RETURNED FOR INVESTIGATION. IN GENERAL IS THE DEVICE IN A USED CONDITION, THERE ARE DISCOLORATIONS VISIBLE, THE HEXAGON RECESS HAS TRACES OF USE AND THE THREAD FLANKS ARE PARTIALLY DAMAGED. AFTERWARDS IT CANNOT BE DEFINED IF THESE DAMAGES WERE CAUSED DURING INSERTION, IN SITU OR DURING EXTRACTION. DIMENSIONAL INSPECTION: CHECKED CORE DIAMETER AT THE FRACTURE ZONE, OUTER DIAMETER, SCREW LENGTH (TO DEFINE LENGTH OF MISSING PIECE) PER RELEVANT DRAWINGS AND ARE WITHIN SPECIFICATIONS. DRAWING/SPECIFICATION REVIEW: RELEVANT DRAWING WAS REVIEWED TO VERIFY THE DIMENSIONS AND THE MATERIAL OF THE NAIL. THE MATERIAL CERTIFICATE OF THE USED ROUND 20046 WITH LOT 20046 WAS REVIEWED. THE REVIEW HAS SHOWN THAT THE MATERIAL OF THE PFNA NAIL IS (B)(4) ACCORDING TO NORM ISO (B)(4) FOR IMPLANTS FOR SURGERY. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE RECEIVED LOCKING BOLT IS BROKEN. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN MARCH 2017, ALL DEVICES ARE DISTRIBUTED AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT NUMBER COMBINATION (INCLUDING STERILE LOT L461094). THIS AND THE FINDINGS ABOVE LET US EXCLUDE A MANUFACTURING RELATED ISSUE. THE LOCKING BOLT WAS RETURNED AS CONCOMITANT DEVICE WITHOUT AN ALLEGATION AGAINST IT. THE BREAKAGE OF THE BOLT WAS DETECTED DURING THE FIRST INSPECTION OF THE PARTS. IT IS UNKNOWN HOW OR WHEN THE DEVICE BROKE, THERE THE CAUSE OF THIS BREAKAGE CANNOT BE DEFINED. BASED ON THE FRACTURE APPEARANCE 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. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A BROKEN PROXIMAL FEMORAL NAIL ADVANCED (PFNA) NAIL. THE NAIL WAS DISCOVERED BROKEN A FEW WEEKS PRIOR TO THE REVISION PROCEDURE. THE DEVICE WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. THERE WAS A SURGICAL DELAY OF ONE HUNDRED AND FIFTY (150) MINUTES. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. PATIENT AND PROCEDURE OUTCOME WAS REPORTED AS GOOD. DURING MANUFACTURER'S ANALYSIS OF THE RETURNED DEVICES, IT WAS IDENTIFIED THAT THE 4.9MM TI LOCKING BOLT 50MM IS ALSO BROKEN. CONCOMITANT DEVICES REPORTED: PFNA BLADE (PART# 04.027.035S, LOT# 1L89539, QUANTITY 1), 4.9MM TI LOCKING BOLT 42MM (PART# 459.420, LOT# 5943522, QUANTITY 1) . THIS REPORT IS FOR ONE (1) 4.9MM TI LOCKING BOLT 50MM. THIS IS REPORT 2 OF 2 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754032 4.9MM TI LOCKING BOLT 50MM PIN,FIXATION,SMOOTH HTY OBERDORF SYNTHES PRODUKTIONS GMBH 5942370 07611819043190

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention