BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9.0MM MEDULLARY REAMER HEAD

    MDR report key: 4915550 · Received July 15, 2015

    Report

    Report Number
    2520274-2015-14933
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    July 4, 2015
    Report Date
    July 4, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JUNE 7, 2002. THE DEVICE HISTORY RECORDS ARE NOT AVAILABLE AS DEVICE IS OLDER THAN TEN (10) YEARS. ACCORDING TO POLICY, THE DOCUMENTS FOR INSTRUMENTS HAVE TO BE STORED FOR 10 YEARS. PRODUCT INVESTIGATION SUMMARY: IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL PROCEDURE PERFORMED ON THE RIGHT FEMUR, A 5.0 FLEXIBLE REAMER SHAFT (PART 352.040 / LOT 2072702) AND 9.0MM REAMER HEAD (PART 352.090 / LOT 2031017) BROKE WHILE THE SURGEON WAS REAMING THE PATIENT'S CANAL. THE DEVICES BROKE INSIDE THE PATIENT¿S FEMORAL CANAL AND THE SURGEON REPORTEDLY REMOVED THE BROKEN PIECES USING A CURVED CURETTE AND COKER INSTRUMENTS. THIS DELAYED THE SURGERY FOR APPROXIMATELY 15 MINUTES. X RAYS WERE TAKEN TO CONFIRM THAT ALL OF THE PIECES WERE REMOVED AND IT WAS REPORTED THAT THE PATIENT DID NOT SUFFER ANY ADDITIONAL INJURIES AS THE SURGEON WAS ABLE TO ENTER THROUGH THE CAVITY THAT HE HAD ALREADY CREATED. THE COMPLAINT CONDITION FOR THE MEDULLARY REAMER HEAD AND FLEXIBLE SHAFT WAS LIKELY CAUSED BY YEARS OF USE AND WEAR; THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE 9.0MM MEDULLARY REAMER HEAD AND 5.0MM FLEXIBLE SHAFT ARE INSTRUMENTS ROUTINELY USED IN THE FLEXIBLE REAMERS FOR INTRAMEDULLARY NAILS SYSTEM. THE SHAFT AND HEAD WERE RETURNED AND REPORTED TO HAVE BROKEN WHILE REAMING THE PATIENT¿S FEMUR. THIS CONDITION IS CONFIRMED; THE REAMER HEAD WAS RETURNED IN THREE PIECES OF THE REAMER HEAD IS BROKEN OFF AND TWO OF THE FOUR PRONGS OF THE FLEXIBLE SHAFT HAVE BROKEN OFF THE DISTAL PORTION OF THE DEVICE. THE SHAFT WAS MANUFACTURED IN SEPTEMBER, 2003 AND IS TWELVE YEARS OLD. THE HEAD WAS MANUFACTURED IN JUNE, 2002 AND IS THIRTEEN YEARS OLD. IT IS LIKELY THAT WEAR AND TEAR FOR MULTIPLE USE INSTRUMENTS LED TO THE COMPLAINT CONDITION. THE REAMER HEAD IS IN FAIRLY POOR CONDITION AND THE CUTTING EDGE IS DULL. THE BALANCE OF THE FLEXIBLE SHAFT IS IN VERY WORN CONDITION. THE ASSOCIATED DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. IT IS LIKELY THAT WEAR AND TEAR FOR MULTIPLE USE INSTRUMENTS LED TO THE COMPLAINT CONDITION. THE REAMER HEAD IS IN FAIRLY POOR CONDITION AND THE CUTTING EDGE IS DULL. THE BALANCE OF THE FLEXIBLE SHAFT IS IN VERY WORN CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 AN INTRAMEDULLARY NAIL PROCEDURE PERFORMED ON THE RIGHT FEMUR, A 5.0 FLEXIBLE REAMER SHAFT AND REAMER HEAD BROKE WHILE THE SURGEON WAS REAMING THE PATIENT'S CANAL. THE DEVICES BROKE INSIDE THE PATIENT¿S FEMORAL CANAL AND THE SURGEON REPORTEDLY REMOVED THE BROKEN PIECES USING A CURVED CURETTE AND COKER INSTRUMENTS. THIS DELAYED THE SURGERY FOR APPROXIMATELY 15 MINUTES. X-RAYS WERE TAKEN TO CONFIRM THAT ALL OF THE PIECES WERE REMOVED AND IT WAS REPORTED THAT THE PATIENT DID NOT SUFFER ANY ADDITIONAL INJURIES AS THE SURGEON WAS ABLE TO ENTER THROUGH THE CAVITY THAT HE HAD ALREADY CREATED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459057 9.0MM MEDULLARY REAMER HEAD REAMER HTO SYNTHES SELZACH 2031017

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention