BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 6376636 · Received March 3, 2017

    Report

    Report Number
    9612488-2017-10084
    Event Type
    Injury
    Date Received
    March 3, 2017
    Report Date
    February 6, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    PMA / PMN Number
    K110592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR SEVEN (7) DYNAMIC LOCKING SCREWS. FOLLOWING EIGHT SCREWS WERE IMPLANTED ON (B)(6) 2012; HOWEVER IT IS UNKNOWN WHICH SEVEN (7) OUT OF THE EIGHT (8) DYNAMIC LOCKING SCREWS BROKE POSTOPERATIVELY. ALSO IT IS UNKNOWN OUT OF THESE EIGHT SCREWS, WHICH SCREW IS CONCOMITANT SCREW. THE 3.7 MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/50 MM-STERILE (PART # 09.213.050S, LOT # 7751661, QUANTITY 1). THE 3.7 MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/38 MM-STERILE (PART # 09.213.038S, LOT # 7744759, QUANTITY 1). THE 3.7 MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/28 MM-STERILE (PART # 09.213.028S, LOT # 7733939, QUANTITY 4). THE 3.7 MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/48 MM-STERILE (PART # 09.213.048S, LOT # 2822022, QUANTITY 1). THE 3.7 MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/40 MM-STERILE (PART # 09.213.040S, LOT # 7726605, QUANTITY 1). MODEL #/LOT #: UDI: PART # 09.213.050S, LOT # 7751661: UDI: (B)(4). PART # 09.213.038S, LOT # 7744759: UDI: (B)(4). PART # 09.213.028S, LOT # 7733939: UDI: (B)(4). PART # 09.213.048S, LOT # 2822022: UDI: (B)(4). PART # 09.213.040S, LOT # 7726605: UDI: (B)(4). OUT OF THE SEVEN BROKEN SCREWS, FOUR OF THE BROKEN DYNAMIC SCREWS COULD BE REMOVED COMPLETELY ON (B)(6) 2015. FROM THE REMAINING THREE DYNAMIC SCREWS ONLY THE INNER SHAFT COULD BE REMOVED DUE TO A COMPLICATION, THE OUTER SHAFTS WERE LEFT IN PLACE, WHICH WERE REMOVED DURING ANOTHER REVISION SURGERY ON THE (B)(6) 2015. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE HISTORY RECORD REVIEW WAS PERFORMED. PART # 09.213.050S, LOT # 7751661, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 13.FEB.2012, EXPIRY DATE: 01. FEB. 2022. PART # 09.213.038S, LOT # 7744759, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 09. FEB. 2012, EXPIRY DATE: 01. FEB. 2022. PART # 09.213.028S, LOT # 7733939, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23.JAN. 2012, EXPIRY DATE: 01. JAN. 2022. PART # 09.213.048S, LOT # 2822022, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 09. FEB. 2012, EXPIRY DATE: 01. FEB. 2022. PART # 09.213.040S, LOT # 7726605, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24. JAN. 2012, EXPIRY DATE: 01. JAN. 2022: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT DID FEEL STRONG PAIN AFTER THE PSEUDARTHROSIS REVISION PERFORMED ON (B)(6) 2012. FURTHER LABORATORY TESTS AND IMAGING SCANNING WERE MADE. THE X-RAY OF THE LEFT LOWER LEG TAKEN ON (B)(6) 2015 REVEALED ANOTHER FRACTURE OF ONE OF THE FIXATION SCREWS, WHICH REQUIRED REFERRING THE PATIENT TO UNDERGO ANOTHER SURGERY TO REMOVE THE FIXATION MATERIAL IN THE LEFT LOWER LEG. THIS SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2015. DURING THE PROCEDURE IT WAS FOUND OUT THAT SEVEN OUT EIGHT FIXATION SCREWS WERE BROKEN. IT WAS POSSIBLE TO REMOVE THE ONE INTACT SCREW AND THE LCP PLATE. FOUR OF THE BROKEN DYNAMIC SCREWS COULD BE REMOVED COMPLETELY. FROM THE REMAINING THREE DYNAMIC SCREWS ONLY THE INNER SHAFT COULD BE REMOVED DUE TO A COMPLICATION, THE OUTER SHAFTS WERE LEFT IN PLACE. THE PSEUDARTHROSIS WAS THEN CLEANED - SPECIMEN COLLECTED FOR MICROBIOLOGICAL TESTS, BONE MARROW CAVITIES MADE PATENT USING THE JUDET METHOD. GROWTH AGENTS OF AUTOGENIC ORIGIN ADMINISTERED. LAYERED STITCHES. STERILE DRESSING. FEMORAL PLASTER CAST. THIS REPORT ADDRESSES THE REVISION SURGERY PERFORMED DUE TO SEVEN BROKEN SCREWS. THE PSEUDARTHROSIS REVISION PERFORMED ON (B)(6) 2012 HAS BEEN CAPTURED UNDER LINKED (B)(4) AND THE INTRAOPERATIVE COMPLICATIONS OCCURRED DURING THE REMOVAL OF SEVEN BROKEN SCREWS HAS BEEN CAPTURED UNDER LINKED (B)(4). CONCOMITANT DEVICES REPORTED: LCP DISTAL TIBIAL PLATE (PART 239.909, QUANTITY 1), UNKNOWN INTACT DYNAMIC LOCKING SCREW STARDRIVE (QUANTITY 1). THIS REPORT IS FOR SEVEN (7) UNKNOWN DYNAMIC LOCKING SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159831 SCREW,FIXATION,BONE HWC SYNTHES BETTLACH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ONE (1) LCP DISTAL TIBIAL PLATE (PART 239.909)| ONE (1) UNK INTACT DYNAMIC LOCKING SCREW STARDRIVE