BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 46MM

    MDR report key: 6093509 · Received November 10, 2016

    Report

    Report Number
    2520274-2016-15339
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 19, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN VA LOCKING SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HRS. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR BOTH POTENTIAL LOT NUMBERS: STERILE PART 04.211.046S, LOT 9404134: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: MARCH 12, 2015. EXPIRY DATE: MARCH 01, 2025. ARTICLE WAS STERILIZED BY (B)(4). NON-STERILE PART 04.211.046, LOT 7893760: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JANUARY 13,2015. STERILE PART 04.211.046S, LOT 9210034: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: OCTOBER 22, 2014. EXPIRY DATE: OCTOBER 01, 2024. ARTICLE WAS STERILIZED BY (B)(4). NON-STERILE PART 04.211.046, LOT 7802891: MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: SEPTEMBER 23, 2014. NO NON-CONFORMANCE REPORTS 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. 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: THE PATIENT UNDERWENT AN EXPLANT SURGERY ON OCTOBER 18, 2016. DURING THE SURGERY, THE SURGEON FACED SOME TROUBLE, SO A VARIABLE ANGLE (VA) LOCKING SCREW REMAINED IN THE PATIENT'S BODY. REPORTED CONCOMITANT DEVICES: VA OLECRANON PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN UNKNOWN VA LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON COULD NOT REMOVE THE VA LOCKING SCREW WHICH HAD BEEN IMPLANTED AT THE PROXIMAL SIDE. HE CUT THE SCREW HEAD TO REMOVE THE PLATE AND THE SHAFT OF THE SCREW REMAINED IN THE BODY. THE SURGERY WAS PROLONGED BY FIFTEEN (15) MINUTES. THE ORIGINAL SURGERY WAS PLATE FIXATION FOR THE PROXIMAL ULNA ON (B)(6) 2016. CONCOMITANT MEDICAL PRODUCTS: VA OLECRANON PLATE (PART: UNKNOWN, LOT: 7791864, QUANTITY: 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744996 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 46MM SCREW, FIXATION, BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 1 UNKNOWN VA OLECRANON PLATE