BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 40MM

    MDR report key: 6334823 · Received February 15, 2017

    Report

    Report Number
    3009417901-2017-10003
    Event Type
    Injury
    Date Received
    February 15, 2017
    Report Date
    January 20, 2017
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HTY
    UDI-DI
    07611819043145
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: JDW, JDS, JDN, HSB. THERAPY DATA: (B)(6) 2015, EXACT DATE IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON PART # 459.400, LOT # 5907405. MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 12. AUG. 2010. NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS PERFORMED ON THE SUBJECT DEVICE (PART # 459.400, LOT # 5907405, 4.9MM TI LOCKING BOLT 40MM). THE BOLT IS BROKEN APART AT THE SHAFT ABOUT 19MM BELOW THE HEAD. THE FRONT PART OF THE BOLT WAS NOT SENT BACK. THERE ARE DIFFERENT DISCOLORATIONS VISIBLE AND THE THREAD FLANKS ARE FLATTENED. THE HEXAGON RECESS HAS SIGNS OF FORCIBLE USE. THE RELEVANT DIMENSIONS OF THE BOLT WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING, DIMENSIONS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-11 FOR IMPLANTS FOR SURGERY, WROUGHT TITANIUM ALUMINIUM NIOBIUM ALLOY. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED. THE LOT IN QUESTION WAS MANUFACTURED WITH A LOT SIZE OF (B)(4) PIECES IN AUGUST 2010 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER. THE EVALUATION OF THE BOLT HAS SHOWN THAT THERE ARE DIFFERENT DISCOLORATIONS VISIBLE AND THAT THE THREAD FLANKS ARE PARTIALLY FLATTENED. THE HEXAGON RECESS IS SLIGHTLY DEFORMED IN A WAY THAT INDICATES FORCIBLE USE. BUT AFTERWARDS IT CANNOT BE DEFINED IF THESE DAMAGES OCCURRED DURING THE INSERTION, IN-SITU OR DURING EXTRACTION OF THE DEVICES. THE ANODIZED LAYER IS WORN AWAY AT ALL DAMAGES, WHICH SHOWS THAT THEY WERE CAUSED POST-MANUFACTURING. 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. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. (THERAPY DATE): UNKNOWN. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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

    THE IMPLANTS WERE ORIGINALLY PUT IN (B)(6) 2015, EXACT DATE IS UNKNOWN. THE EXACT ORIGINAL INJURY IS NOT KNOWN, BUT IT WAS SAID THAT THE PATIENT WAS INJURED IN SIMILAR CIRCUMSTANCES AT THIS TIME I.E. A FALL. THE PATIENT HAD BEEN TAKING LONG TERM NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) AND SURGEON BELIEVES THAT CONSIDERING THE PATIENT WAS NOT OVERWEIGHT AND DID NOT HAVE A HISTORY OF SMOKING, THIS HAD CONTRIBUTED TO THE NON-UNION RESULTING IN THE SECOND SURGERY.

    Description of Event or Problem · 1

    DEVICE REPORT SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 DUE TO POSTOPERATIVE BREAKAGE OF A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) AND ONE (1) LOCKING BOLT. THE BROKEN DEVICES WERE REMOVED ALONG WITH ONE (1) INTACT LOCKING BOLT AND ONE INTACT PFNA BLADE. THE INITIAL DATE OF IMPLANT IS UNKNOWN. CONCOMITANT REPORTED PART: 1X LOCKING BOLT (PART 459.420 LOT 5933813); 1X PFNA BLADE (PART 04.027.033S LOT 9510091). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116955 4.9MM TI LOCKING BOLT 40MM PIN,FIXATION,SMOOTH HTY SYNTHES SALZBURG 5907405 07611819043145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 04.027.033S, PFNA BLADE TAN 90MM| 459.420, 4.9MM TI LOCKING BOLT 42MM