BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT Ø3.9 SELF-TAP L36 TAN DBLUE

    MDR report key: 6823886 · Received August 28, 2017

    Report

    Report Number
    3000270450-2017-10309
    Event Type
    Injury
    Date Received
    August 28, 2017
    Report Date
    August 7, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE PATIENT PAIN BEGAN IS NOT KNOWN. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    DHR REVIEW WAS COMPLETED FOR 459.360S, LOT 9302995, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 31. DEC. 2014 EXPIRY DATE: 01.DEC.2024. NO 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. NON-STERILE 459.360 / 5932265,. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE:11. DEC. 2014. NO 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. 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 PATIENT UNDERWENT SURGERY ON (B)(6) 2015 TO IMPLANT A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL, BLADE, AND LOCKING BOLT. PATIENT EXPERIENCED PERSISTENT PAIN AND CONSULTED ANOTHER SURGEON WHO NOTED A ¿WIPER EFFECT¿ OF THE FASCIA LATA TENSOR. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 FOR REMOVAL OF THE HARDWARE. DURING THE REMOVAL PROCEDURE, SURGEON NOTED AN END CAP WAS NOT USED, STATING THE ABSENCE OF THE END CAP COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S PERSISTENT PAIN AND SOFT TISSUE IRRITATION. THIS REPORT IS FOR ONE (1) PFNA BOLT. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603598 BOLT Ø3.9 SELF-TAP L36 TAN DBLUE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES SELZACH 9302995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention