BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 6376653 · Received March 3, 2017

    Report

    Report Number
    9612488-2017-10085
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    February 27, 2015
    Report Date
    February 6, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    PMA / PMN Number
    K110592
    Adverse Event
    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 THREE (3) DYNAMIC LOCKING SCREWS. FOLLOWING EIGHT SCREWS WERE INITIALLY IMPLANTED; HOWEVER IT IS UNKNOWN WHICH OF THE THREE (3) DYNAMIC LOCKING SCREWS DID CONTRIBUTE TO THE FRACTURE AND WERE LEFT IN THE PATIENT. 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 #: PART # 09.213.050S, LOT # 7751661: UDI: (01)GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE (B)(4). PART # 09.213.038S, LOT # 7744759: UDI: (01)GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE (B)(4). PART # 09.213.028S, LOT # 7733939: UDI: (01)GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE (B)(4). PART # 09.213.048S, LOT # 2822022: UDI: (01)GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE (B)(4). PART # 09.213.040S, LOT # 7726605: UDI: (01)GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). DEVICE HISTORY RECORD REVIEW WAS PERFORMED. PART # 09.213.050S, LOT # 7751661, MANUFACTURING LOCATION: BETTLACH, MANUFACTURING DATE: 13.FEB.2012, EXPIRY DATE: 01. FEB. 2022. PART # 09.213.038S, LOT # 7744759, MANUFACTURING LOCATION: BETTLACH, MANUFACTURING DATE: 09. FEB. 2012, EXPIRY DATE: 01. FEB. 2022. PART # 09.213.028S, LOT # 7733939, MANUFACTURING LOCATION: BETTLACH, MANUFACTURING DATE: 23.JAN. 2012, EXPIRY DATE: 01. JAN. 2022. PART # 09.213.048S, LOT # 2822022, MANUFACTURING LOCATION: BETTLACH, MANUFACTURING DATE: 09. FEB. 2012, EXPIRY DATE: 01. FEB. 2022. PART # 09.213.040S, LOT # 7726605, MANUFACTURING LOCATION: BETTLACH, 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 DURING A REVISION SURGERY OF SEVEN (7) BROKEN SCREW THE BONE DID FRACTURE AT ONE SCREW PENETRATION SITE. THE DYNAMIC LOCKING SCREW WAS SCREWED INTRACORTICALLY AFTER PREVIOUS CORTICAL ONE. THEREFORE THE REMOVAL OF THE REMAINING BROKEN SCREWS WAS RESIGNED FROM AND 3 SCREW FRAGMENTS WERE LEFT IN THE PATIENT. FINALLY IT WAS POSSIBLE TO REMOVE THE FRAGMENTS DURING ANOTHER REVISION SURGERY ON THE (B)(6) 2015. THIS SURGERY WAS PERFORMED DUE DO A PSEUDARTHROSIS OF THE FRACTURE THAT WAS TREATED WITH A CAST AFTER THE LAST REVISION. THIS REPORT ADDRESSES THE INTRAOPERATIVE ISSUE OF BONE FRACTURE AT ONE SCREW PENETRATION DURING THE REVISION SURGERY. THE REVISION SURGERY PERFORMED DUE TO SEVEN BROKEN SCREWS HAS BEEN CAPTURED UNDER LINKED (B)(4). THIS REPORT IS FOR THREE (3) UNKNOWN DYNAMIC LOCKING SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159963 SCREW,FIXATION,BONE HWC SYNTHES BETTLACH

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention