BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 54MM F/IM NAILS-STER

    MDR report key: 6284021 · Received January 27, 2017

    Report

    Report Number
    3000270450-2017-10023
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 7, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HSB
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THE EVENT DATE IS UNKNOWN. THE REPORTED EVENT DATE OF (B)(6) 2017 IS THE DATE THE REPORTED SCREW MIGRATION WAS DISCOVERED. OTHER NUMBER¿UDI: (B)(4). EXPLANT DATE: UNKNOWN. INITIAL REPORTING FACILITY PHONE NUMBER IS (B)(6). SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE: MAR 27, 2013. EXPIRATION DATE: MAR 1, 2023. 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. (B)(4). 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 NARRATIVE: ADDITIONAL PRODUCT CODE: HWC. A PRODUCT INVESTIGATION WAS COMPLETED: PRODUCT WAS NOT RETURNED AND AN INVESTIGATION COULD NOT BE PERFORMED WITHOUT MATERIAL. COMPLAINED ISSUE (LOCKING SCREW IN QUESTION WAS IN CONDITION OF BACKED OUT) COULD BE CONFIRMED BASED ON ATTACHED X-RAY. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED CONFORMITY. NO MANUFACTURING DEVIATION COULD BE DETECTED WITH THE CURRENT AVAILABLE INFORMATION. THE DEVICE HISTORY RECORD FOR BOTH THE STERILE AND NON-STERILE VERSIONS OF THE PART WERE REVIEWED. STERILE PART 04.005.444S, LOT 8332587: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: MARCH 27, 2013, EXPIRY DATE: MARCH 01, 2023. NON-STERILE PART 04.005.444, LOT 8325292: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: FEBRUARY 27, 2013. 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. ROOT CAUSE COULD NOT BE DEFINED DUE THE MISSING MATERIAL. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE SURGEON CONFIRMED BY X-RAY THE LOCKING SCREW, HAD BACKED OUT POSTOPERATIVELY. THE PATIENT HAD INITIALLY BEEN IMPLANTED ON (B)(6) 2016 TO TREAT A PROXIMAL HUMERAL FRACTURE. SURGICAL REVISION TO EXTRACT THE SCREW WAS PLANNED FOR AN UNKNOWN DATE AFTER THE NEXT WEEK (WEEK AFTER (B)(6) 2017). THERE IS NO INFORMATION AVAILABLE ABOUT SURGICAL OUTCOME. THE PATIENT IS UNDER FOLLOW-UP; EXTRACTION SURGERY IS NOT DONE YET. CONCOMITANT DEVICE: A 1X 04.016.035S / 5939816 OR 5940123 (MULTILOC PHN Ø8 LE CANN L160 TAN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66358 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 54MM F/IM NAILS-STER ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES SELZACH 8332587

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 04.016.035S, 8MM TI MULTILOC PROX HUMERAL NAIL