BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE/SCREW EXTRACTOR

    MDR report key: 6293798 · Received February 1, 2017

    Report

    Report Number
    3003875359-2017-10047
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 10, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HSB
    UDI-DI
    10886982070463
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE RETURNED DEVICE IS CONFIRMED TO BE BROKEN AT THE THREADED TIP. THE TIP IS COMPLETELY SHEARED OFF. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. THE FOLLOWING DRAWINGS WERE REVIEWED DURING INVESTIGATION. (B)(4). THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE ROOT CAUSE IS LIKELY RELATED TO APPLICATION OF EXCESSIVE TORQUE ON THE DEVICE. AS THE IMPLANT HAS BEEN IN SINCE 2006 THERE IS LIKELY SIGNIFICANT BONE GROWTH AROUND THE DEVICE. 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. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.037.030, LOT# 9163436. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: DEC 12, 2014. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 ON (B)(6) 2017, PATIENT UNDERWENT REVISION PROCEDURE. DURING THE PROCEDURE, A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SCREW EXTRACTOR WAS USED TO REMOVE A TROCHANTERIC FIXATION NAIL (TFN). POST-OPERATIVELY, IT WAS DISCOVERED THAT THE TIP ON THE EXTRACTOR BROKE OFF INSIDE THE LAG SCREW AT AN UNKNOWN TIME. THE ORIGINAL IMPLANT DATE WAS ON AN UNKNOWN DATE IN 2006. ALL REMOVED HARDWARE WAS REMOVED INTACT WHICH INCLUDED ONE SHORT NAIL, ONE LAG SCREW AND ONE 5.0MM SCREW. THE PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE REASON FOR REVISION PROCEDURE IS COVERED UNDER (B)(4). CONCOMITANT MEDICAL PRODUCTS: LAG SCREW (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY 1); TFN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); 5.0MM SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HELICAL BLADE/SCREW EXTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76633 HELICAL BLADE/SCREW EXTRACTOR ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES HAGENDORF 9163436 10886982070463

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR ONE (1) UNKNOWN 5.0MM SCREW| ONE (1) UNKNOWN LAG SCREW| ONE (1) UNKNOWN TFN NAIL