BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI TROCH FIXATION NAIL SCREW/110MM - STERILE

    MDR report key: 6926910 · Received October 7, 2017

    Report

    Report Number
    1719045-2017-11031
    Event Type
    Injury
    Date Received
    October 7, 2017
    Report Date
    September 21, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K092646
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF DEVICE ¿CUT OUT¿ IS NOT KNOWN. ADDITIONAL PRODUCT CODE: HWC. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW. PART NUMBER: 04.032.110S, SYNTHES LOT NUMBER: 9843082, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 10-JUL-2015, EXPIRATION DATE: 31-MAY-2025, MANUFACTURED BY SYNTHES (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH 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

    IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO REVISION OF A TROCHANTERIC FIXATION NAIL (TFN) SHORT NAIL DUE TO CUT-OUT OF THE LAG SCREW ON (B)(6) 2017. THE PATIENT HAD ORIGINALLY UNDERGONE SURGERY ON (B)(6) 2017 AND WAS IMPLANTED WITH THE SHORT NAIL, A LAG SCREW, AND A 5 MM LOCKING SCREW. HOWEVER, AT A LATER DATE POSTOPERATIVELY (EXACT DATE UNKNOWN) IT WAS DISCOVERED THROUGH AN X-RAY THAT THE LAG SCREW HAD CUT OUT. THE X-RAY SHOWED THAT FIVE (5) MM OF THE LAG SCREW WERE OUTSIDE OF THE FEMORAL HEAD. IT WAS CONCLUDED REVISION SURGERY WAS NEEDED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2017. THE PATIENT WAS REVISED TO A STRYKER TOTAL HIP. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. CONCOMITANT DEVICES REPORTED: 5.0 MM LOCKING SCREW (PART 04.005.534, LOT NUMBER 9815462, QUANTITY 1), 11 MM 130 DEGREE CANNULATED TFN NAIL 170 MM (SHORT NAIL) (PART 456.318, LOT NUMBER H150562, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11.0 MM TFN SCREW 110 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706343 11.0MM TI TROCH FIXATION NAIL SCREW/110MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9843082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention