BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING SCREWDRIVER HANDLE

    MDR report key: 6285569 · Received January 30, 2017

    Report

    Report Number
    9680938-2017-10012
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Report Date
    January 9, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXX
    UDI-DI
    10887587036250
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. ONE RATCHETING SCREWDRIVER HANDLE (PART NUMBER 311.23 / LOT NUMBER T113394) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKEN: PROCEDURAL STEP UNKNOWN.¿ THE COMPLAINT CONDITION IS CONFIRMED BUT DIFFERS SLIGHTLY FROM THE REPORTED CONDITION IN THAT THE DEVICE IS CRACKED; NOT BROKEN INTO SEPARATE PIECES. AS THE CIRCUMSTANCES AT THE TIME OF THE ISSUE AND OVER THE LIFESPAN OF THE DEVICE ARE UNKNOWN A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE RETURNED CONDITION IS CONSISTENT WITH THE HANDLE BEING EXPOSED TO EXCEEDING FORCES RESULTING IN CRACKING OF THE DISTAL PORTION OF THE CYLINDRICAL HANDLE. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE RETURNED SCREWDRIVER HANDLE IS INTENDED FOR USE ACROSS VARIOUS PLATING SYSTEMS. THE DEVICE IS REFERENCED IN THE MATRIXMANDIBLE, MATRIXRIB, TITANIUM STERNAL FIXATION AND THE MATRIXWAVE MMF SYSTEM TECHNIQUE GUIDES. THE HANDLE WAS RECEIVED WITH A CRACK IN THE DISTAL PORTION OF THE CYLINDRICAL HANDLE. THE CRACK EXTENDS BETWEEN THE DISTAL EDGE OF THE HANDLE TO THE CORNER OF THE RATCHETING SWITCH. NO MISSING PORTIONS WERE IDENTIFIED AND THE HANDLE IS RETAINED ON THE SHAFT OF THE DEVICE. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE. THE RATCHETING MECHANISM WAS FOUND TO FUNCTION AS INTENDED. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT DIFFERS SLIGHTLY FROM THE REPORTED CONDITION IN THAT THE DEVICE IS CRACKED; NOT BROKEN INTO SEPARATE PIECES. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY CRACKED. BASED ON THE DATE OF MANUFACTURED THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. SCREWDRIVER BODY, RATCHETING: 311_023 THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. (ALL DIMENSIONAL INSPECTIONS COMPLETED WITH CALIPERS). 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

    ADDITIONAL NARRATIVE: MANUFACTURING DATE: APRIL 22, 2015. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL PARTS OF THE LOT WERE CHECKED 100% FOR IMPORTANT FEATURES AS WELL AS FOR FUNCTION WITH A SPECIAL GAGE AT THE FINAL INSPECTION. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE HANDLE WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE HANDLE WAS CRACKED. HANDLE CRACKED/BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. 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 USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODE: DZJ, DRIVER,WIRE,BONE DRILL MANUAL. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. A DEVICE HISTORY RECORD REVIEW (DHR) WAS REQUESTED A SERVICE & REPAIR EVALUATION/REVIEW WAS ATTEMPTED; NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 311.023 WITH LOT NUMBER(S) T113394 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 30-APR-2016. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. PART 1 OF 1. 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

    CORRECTED DATA: BRAND NAME, COMMON DEVICE NAME, DEVICE PRODUCT CODE, ADDITIONAL DEVICE PRODUCT CODE: LXH, CATALOG NUMBER, UDI NUMBER, 510K NUMBER. REPORTED ON MEDWATCH REPORT MW (B)(4) CORRECTED TO "A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. ONE RATCHETING SCREWDRIVER HANDLE (PART NUMBER 311.023 / LOT NUMBER T113394) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF BROKEN: PROCEDURAL STEP UNKNOWN.¿ 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

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT SYNTHES EVALUATION EQUIPMENT FAILED INSPECTION-BROKEN HANDLE-ISSUE IDENTIFIED DURING SERVICE & REPAIR ACTIVITIES OF THE EVALUATION SET. THERE WERE NO ISSUES REPORTED BY THE CUSTOMER. THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70909 RATCHETING SCREWDRIVER HANDLE SCREWDRIVERS HXX SYNTHES TUTTLINGEN T113394 10887587036250

    Patients

    Seq Age Sex Outcome Treatment
    1