BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø10 LONG R 130° L360 TAN

    MDR report key: 6334822 · Received February 15, 2017

    Report

    Report Number
    9612488-2017-10057
    Event Type
    Injury
    Date Received
    February 15, 2017
    Report Date
    January 20, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. (B)(4). (THERAPY DATE): UNKNOWN. (B)(6). THE 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: JUN 18, 2014. EXPIRATION DATE: JUN 1, 2024. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    THERAPY DATA: (B)(6) 2015, EXACT DATE IS UNKNOWN. A MANUFACTURING INVESTIGATION WAS PERFORMED ON THE SUBJECT DEVICE (PART # 04.027.226S, LOT # 9022881, PFNA Ø10 LONG R 130° L360 TAN) THE NAIL IS BROKEN APART AT THE SHAFT ABOUT 18MM BELOW THE CONE/CROSSOVER TO THE UPPER PART. THERE ARE DIFFERENT DISCOLORATIONS VISIBLE AND ALL HOLES ARE DAMAGED. THE RELEVANT DIMENSIONS OF THE PFNA 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 JUNE 2014 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER. THE EVALUATION HAS SHOWN THAT THE BLADE AND AS WELL THE BOLT HOLES ARE DAMAGED. 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. 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 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 1 OF 2 FOR (B)(4).

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116950 PFNA Ø10 LONG R 130° L360 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 9022881

    Patients

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