BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 8711813 · Received June 19, 2019

    Report

    Report Number
    2939274-2019-58739
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Report Date
    May 21, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982194114
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 352.040. LOT: 7771080. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: 27.FEB.2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE 5.0MM FLEXIBLE SHAFT (P/N 352.040 LOT 7771080) WAS BROKEN INTO TWO (2) PIECES AT THE SHAFT. THE TRANSVERSE FRACTURE WAS 205.39 MM (CA472) FROM THE DISTAL END OF THE COUPLING PRONGS. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DIMENSIONAL INSPECTION: SHAFT DIAMETER ADJACENT TO FRACTURE WAS MEASURED AND FOUND TO BE CONFIRMING PER RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWINGS, REFLECTING THE MANUFACTURED AND CURRENT REVISIONS, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE 5.0MM FLEXIBLE SHAFT (P/N 352.040 LOT 7771080) AS THE INSTRUMENT WAS BROKEN INTO TWO (2) PIECES AT THE SHAFT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED MECHANICAL OVERLOAD DURING USE AND/OR UNINTENDED FORCES. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 AN UNKNOWN DATE, DURING STANDARD APPROACH NON-SUPRAPATELLAR TIBIAL NAILING, THE FLEXIBLE SHAFT SNAPPED IN HALF WHILE IN THE MEDULLARY CANAL OF PATIENT. UPON THE FIRST REAMING PASS, THE REAMER SHAFT WAS APPROXIMATELY HALFWAY DOWN THE CANAL, NOT THE FRACTURE SITE, WHEN A LOUD AUDIBLE SOUND WAS HEARD THAT WAS NOT NORMAL CHATTER. THE REAMER SHAFT WOULD NOT ADVANCE ANY FURTHER. THEY CHECKED BY X-RAY TO FIND THAT THE REAMER SHAFT HAD SNAPPED IN HALF IN THE MEDULLARY CANAL. THE SURGEON THEN PULLED THE DRILL SYNTHES SMALL BATTERY DRIVE WITH REAMING ATTACHMENT OUT WITH HALF OF THE REAMER SHAFT STILL ATTACHED. A JACOBS CHUCK T HANDLE ATTACHED TO THE REAMING ROD WAS USED TO PULL THE SECOND HALF OF THE REAMER SHAFT AND HEAD OUT OF THE PATIENT. NO ISSUES OCCURRED UPON REMOVAL. THE BROKEN REAMER SHAFT WAS REMOVED IN TWO PIECES. ONE PIECE ATTACHED TO DRILL, SECOND PIECE WAS REMOVED USING BALL TIP REAMING ROD. A NEW REAMING ROD WAS PASSED WITH A DIFFERENT REAMER SHAFT. THE REMAINING STEPS OF THE PROCEDURE PROCEEDED WITH NO FURTHER ISSUES. THERE WERE NO FRAGMENTS GENERATED IN THE BROKEN DEVICE. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDE WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN DRILL BIT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) UNKNOWN REAMING ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504044 5.0MM FLEXIBLE SHAFT REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 352.040 7771080 10886982194114

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR UNK - DRILL BITS: TRAUMA| UNK - GUIDE/COMPRESSION/K-WIRES| UNK - REAMING RODS| UNK - DRILL BITS: TRAUMA| UNK - GUIDE/COMPRESSION/K-WIRES| UNK - REAMING RODS