BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNREAM REAMING ROD Ø2.5 LONG L1150

    MDR report key: 6359851 · Received February 26, 2017

    Report

    Report Number
    2520274-2017-10599
    Event Type
    Injury
    Date Received
    February 26, 2017
    Date of Event
    January 27, 2017
    Report Date
    January 31, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    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. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. (B)(6). 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. (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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. TWO (2) PHOTOGRAPHS OF THE SUBJECT DEVICES WERE PROVIDED TO THE MANUFACTURER. BASED ON THE PHOTOGRAPHS AND EVENT DESCRIPTION, THE COMPLAINT CONDITION OF BENT/TWISTED IS CONFIRMED. THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE, A CONCLUSIVE STATEMENT REGARDING THE POSSIBLE REASONS (ROOT CAUSE) FOR THE COMPLAINT ISSUE CANNOT BE MADE. A LOT NUMBER WAS NOT PROVIDED AND WITHOUT A LOT NUMBER, A DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. 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 REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY DURING THE START OF IMPACTION OF THE EXPERT TIBIAL NAIL THROUGH THE GUIDE, THE NAIL DID WAS NOT ABLE TO PASS AND WHEN TAKING X-RAYS IT WAS EVIDENT THAT THE INTRAMEDULLARY GUIDE WAS COMPLETELY TWISTED. THE GUIDE WAS CHANGED AND THE SAME HAPPENED WITH THE OTHER ONE; EVERYTHING WAS STUCK INSIDE THE TIBIA AND WHEN THE RETREAT WAS FORCED, THE TIBIA FRACTURED IN THE SHAFT. THE SURGERY WAS SUCCESSFULLY COMPLETED BUT WAS PROLONGED BY 30 MINUTES DUE TO THE REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: EXPERT TIBIAL NAIL (PART / LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION AND EVENT CLARIFICATION WERE RECEIVED ON (B)(6) 2017. IT WAS REPORTED THAT DURING A TIBIA SURGERY, WHILE IMPACTING THE EXPERT TITANIUM NAIL THROUGH THE SYNREAM REAMING ROD, THE NAIL COULD NOT PASS THROUGH. WHEN TAKING X-RAYS IT WAS EVIDENT THAT THE SYNREAM REAMING ROD WAS COMPLETELY TWISTED. THE SYNREAM REAMING ROD WAS REPLACED WITH ANOTHER SYNREAM REAMING ROD AND THE SAME PROBLEM OCCURRED. THE NAIL, SECOND SYNREAM REAMING ROD, AND PROTECTION SLEEVE WERE STUCK INSIDE THE PATIENT¿S TIBIA AND WHEN REMOVAL WAS FORCED, THE TIBIA FRACTURED IN THE SHAFT. THE SURGERY WAS SUCCESSFULLY COMPLETED BUT WAS PROLONGED BY 30 MINUTES DUE TO THE REPORTED EVENT. REPORTED CONCOMITANT DEVICES: EXPERT TITANIUM NAIL (PART / LOT: UNKNOWN, QUANTITY: 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142290 SYNREAM REAMING ROD Ø2.5 LONG L1150 REAMER HTO SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention UNKNOWN EXPERT TIBIAL NAIL, QTY 1