BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE

    MDR report key: 5955919 · Received September 16, 2016

    Report

    Report Number
    2520274-2016-14547
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 31, 2016
    Report Date
    August 31, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES REPORTED: UNKNOWN PROTECTION SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN HANDLE WITH QUICK COUPLING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), THREAD LOCK SLEEVE (PART# 03.835.009S, LOT# 9916325, QUANTITY 1), LOCK SCREW, FINE TIP, 20MM (PART# 04.835.120.02S, LOT# 9911949, QUANTITY 1), LOCK SCREW, FINE TIP, 25MM (PART# 04.835.125.02S, LOT# 9912685, QUANTITY 2), SYNFIX EVOLUTION SPACER, MEDIUM (PART# 08.815.222S, LOT# 9848673, QUANTITY 1), AIMING DEVICE (PART# 08.815.222S, LOT# 9848673, QUANTITY 1). THERAPY DATE: (B)(6) 2016. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. DEVICE 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 ON (B)(6) 2016, A PATIENT UNDERWENT PROCEDURE TO IMPLANT A SYNFIX EVOLUTION DEVICE AT L5-S1. AFTER ATTACHING THE AIMING GUIDE TO THE IMPLANT, WHILE ATTEMPTING TO AWL THE FIRST HOLE AT L5, THE SURGEON COULD NOT PENETRATE THE PATIENT'S VERTEBRAL BODY. UNDER FLUOROSCOPY, THE SURGEON CONFIRMED THAT THE AWL WAS GETTING CAUGHT IN THE AIMING GUIDE AND WOULD NOT ADVANCE INTO THE L5 VERTEBRAL BODY. MULTIPLE ATTEMPTS WERE MADE TO PERFORATE THE CORTEX OF THE VERTEBRAL BODY BUT WERE UNSUCCESSFUL. THE SURGEON TRIED TO PLACE THE SCREW, BUT WAS UNSUCCESSFUL DUE TO THE FAILURE OF THE AWL TO CREATE A PATHWAY. THE SURGEON MADE THE DECISION TO LEAVE THE SYNFIX EVOLUTION SPACER IMPLANTED AND ACHIEVED FIXATION WITH AN ANTERIOR LUMBAR PLATE. A SURGICAL DELAY OF APPROXIMATELY THIRTY (30) MINUTES WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH PATIENT OUTCOME DEEMED AS SUCCESSFUL. THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION AWL/WITHOUT SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609193 SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE AWL HWJ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention