BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 7385443 · Received March 30, 2018

    Report

    Report Number
    2939274-2018-51358
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Report Date
    March 5, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 314.743. SYNTHES LOT NUMBER: 5471386. SUPPLIER LOT NUMBER: 14780-01. RELEASE TO WAREHOUSE DATE: 14-MAR-2007. EXPIRATION DATE: N/A. SUPPLIER: CRITERION TOOL & DIE, INC. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: DEVICE CONDITION: THE DRIVE SHAFT WAS RECEIVED WITH A PORTION OF THE DISTAL TIP, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. THE BROKEN PORTION WAS NOT RECEIVED. THE BREAK IS LOCATED IMMEDIATELY DISTAL TO THE HELIX. THE HELIX IS INTACT BUT IS WORN AND DEFORMED. THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. LOT NUMBER REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE LOT WENT THROUGH THE REQUIRED STEPS DURING THE INSPECTION AT THE TIME OF MANUFACTURING AND THE DHR RECORDS SHOWED NO ISSUES CONCERNING THE MATERIAL. HARDNESS WAS NOT REVIEWED AS THE FLEXIBLE NITINOL SHAFT DOES NOT HAVE A HARDNESS SPECIFICATION (REFERENCE: 314_741_1_2). DRAWING REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. --DRIVE SHAFT ASSEMBLY; RIA: 314_741 AND --DRIVE SHAFT; RIA (COMPONENT): 314_741_1_2. THE OUTER DIAMETER OF THE SHAFT WAS MEASURED TO BE 5.186MM (MICROMETERS: OM803) WHICH IS WITHIN THE SPECIFICATION OF 5.18MM +/- 0.025 PER 314_741_1_2. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION IS THE RESULT OF FORCE APPLIED TO THE DISTAL END OF THE DRIVE SHAFT RESULTING IN STRESSES BEYOND THE FAILURE LIMIT OF THE SHAFT. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE CIRCUMSTANCES AT THE TIME OF THE BREAK ARE UNKNOWN. THE REAMER/IRRIGATOR/ASPIRATOR (RIA) TECHNIQUE GUIDE ADDRESSES RECOMMENDED USE. STEP 5 UNDER ¿ASSEMBLY,¿ STATES THAT A CANNULATED DRIVE UNIT THAT DELIVERS ONLY 3.5-4.5NM OF TORQUE AND 700-900RPM IS TO BE USED. THE TECHNIQUE GUIDE ALSO CAUTIONS THAT NO REDUCTION DRIVE UNITS OR DRILLS WITH A TORQUE GREATER THAN 6NM SHOULD BE USED. STEP 2 UNDER ¿REAMING¿ DESCRIBES THE RECOMMEND USE FOR REAMING AS FOLLOWS; ¿BEGIN REAMING, USING A GRADUAL ADVANCE/RETRACT TECHNIQUE. SLOWLY ADVANCE 20-30MM AND THEN RETRACT 50-80MM ALLOWING THE IRRIGATION FLUID TO FLOW IN FRONT OF THE REAMER HEAD. ADVANCE THE ASSEMBLY UNTIL RESISTANCE IS FELT, THEN REPEAT.¿ CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS DRIVE SHAFT WAS RECEIVED WITH A PORTION OF THE DISTAL TIP, WHICH MATES WITH THE REAMER HEAD, BROKEN OFF. A DEVICE HISTORY RECORD (DHR) REVIEW, DEVICE INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 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. ADDITIONAL CLASSIFICATION CODE: HRX COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MANUFACTURE DATE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THREE RIA DRIVER SHAFTS HAVE BROKEN TIPS. IT WAS DISCOVERED WHEN SALES CONSULTANT WAS PUTTING TRAYS TOGETHER. NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227746 RIA DRIVESHAFT L520 REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.743 5471386 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1