BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 90MM-STERILE

    MDR report key: 5095399 · Received September 22, 2015

    Report

    Report Number
    3003506883-2015-10142
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE: UNKNOWN . IMPLANT DATE: UNKNOWN IMPLANT DATE, SOMETIMES IN (B)(6) 2015, EXACT DATE UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN CONDUCTED. PART MFG DATE: 02/13/2015, PART EXP. DATE: 01/2024, DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 7912790 OF 11.0MM TI HELICAL BLADE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DISPOSITION: UNCONFIRMED, A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (7818863) MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. 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

    (B)(6). PRODUCT WILL NOT BE COMING BACK. EXPIRATION DATE OF PART #456.303S LOT #7912790 IS 01/2024. 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 UNDERWENT A TROCHANTERIC FIXATION NAIL SYSTEM (TFN) INSERTION IN (B)(6) 2015, EXACT DATE UNKNOWN. ON UNKNOWN DATE, AN X-RAY REVEALED THAT THE HELICAL BLADE HAD ADVANCED THROUGH THE FEMORAL HEAD AND INTO THE ACETABULAR CUP. ON (B)(6) 2015 THE HELICAL BLADE WAS REMOVED AND PATIENT WAS REVISED AND A SCREW WAS INSERTED. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: PRODUCT WILL NOT BE RETURNED FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626346 11.0MM TI HELICAL BLADE 90MM-STERILE ROD, FIXATION, INTRAMEDULLARY, SCREW, FIXATION, BONE HSB SYNTHES ELMIRA 7912790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention