BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORACIC PEDICLE PROBE

    MDR report key: 4493992 · Received February 9, 2015

    Report

    Report Number
    1719045-2015-10093
    Event Type
    Injury
    Date Received
    February 9, 2015
    Date of Event
    December 12, 2014
    Report Date
    December 12, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: TELEFLEX MEDICAL, INC. ((B)(4)) MANUFACTURED THE THORACIC PEDICLE PROBE, PART NUMBER 03.622.005, AND LOT 6924212. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE AND WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT.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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE RETURNED DEVICE IS USED WITH THE PANGEA SYSTEM, THE MATRIX DEFORMITY SYSTEM AND USS SYSTEM, THESE TECHNIQUE GUIDES WERE REVIEWED ((B)(4), (B)(4), AND (B)(4)). THIS DEVICE IS USED TO OPEN THE PEDICLE CANAL. THE DEPTH MARKINGS INDICATE THE APPROXIMATE LENGTH OF SCREW WHICH SHOULD BE USED. ONE THORACIC PEDICLE PROBE (PART# 03.622.005, LOT# 6924212, MFG JUN2012) WAS RETURNED WITH THE COMPLAINT THAT ¿THE TIP OF THE SHARP PEDICLE PROBE BROKE OFF IN THE PATIENT'S PEDICLE. THE BROKEN FRAGMENT OF THE TIP WAS TOO DEEP TO RETRIEVE, AND REMAINS IMPLANTED.¿ UPON RECEIPT OF THIS DEVICE IT WAS SEEN THAT THE DISTAL TIP BROKE BETWEEN THE ETCHED 30 AND 40 ON THE SHAFT. THIS COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ULTIMATELY UNKNOWN HOWEVER THIS FAILURE MAY BE THE RESULT OF AN EXTREME LOADING FORCE APPLIED TO THE HANDLE WHILE THE PROBE WAS RIGIDLY FIXED, AND DENSE PATIENT BONE MAY ALSO BE A CONTRIBUTING FACTOR. IF AN EXTREME LOADING FORCE IS APPLIED THIS CAN CAUSE STRESS THAT MAY AFFECT THE TENSILE STRENGTH OF THE MATERIAL. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 DURING A PROCEDURE ON (B)(6) 2014 TO INSTRUMENT THE PATIENT AT LEVELS L4 - S1, THE SURGEON WAS PREPARING A GUIDE HOLE FOR A PEDICLE SCREW ON THE RIGHT L5 PEDICLE. THE TIP OF THE SHARP PEDICLE PROBE BROKE OFF IN THE PATIENT'S PEDICLE. THE BROKEN FRAGMENT OF THE TIP WAS TOO DEEP TO RETRIEVE, AND REMAINS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED BY PLACING SCREWS AT L4, LEFT L5, AND S1 PEDICLES. NO SCREW WAS USED IN THE RIGHT L5 PEDICLE. THERE WAS NO DELAY OR EXTENSION TO SURGICAL TIME DUE TO THE COMPLAINED EVENT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93226 THORACIC PEDICLE PROBE SCREWDRIVERS HXX SYNTHES MONUMENT 6924212

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention