BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CRUCIFORM SCREWDRIVER

    MDR report key: 7778524 · Received August 13, 2018

    Report

    Report Number
    2939274-2018-53307
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 22, 2018
    Report Date
    July 23, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188878
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. DATE DEVICE RECEIVED BY MANUFACTURER. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 · 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. DEVICE HISTORY RECORD (DHR) REVIEW: PART # 314.463; SYNTHES LOT # 6129539; SUPPLIER LOT # NA; COMPONENT LOT # 6113434; RELEASE TO WAREHOUSE DATE: 22APR2009; MANUFACTURED BY SYNTHES BRANDYWINE. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO RELEVANT NON-CONFORMANCE NOTED. NO NONCONFORMANCE RECORDS (NCRS) WERE GENERATED DURING PRODUCTION. 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. INVESTIGATION SUMMARY: BACKGROUND: IT WAS REPORTED THAT DURING AN UNKNOWN TROCHANTERIC FIXATION NAIL-ADVANCED CASE ON (B)(6) 2018, THE TIP OF THE CANNULATED CRUCIFORM SCREWDRIVER BROKE OFF WHILE THE THREADS ON THE GUIDE SLEEVE AND BUTTRESS COMPRESSION NUT WERE BOTH BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT'S STATUS AND SURGICAL OUTCOME WERE BOTH UNKNOWN. INVESTIGATION FLOW: BROKEN. VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF DEVICE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. ALL FOUR DISTAL CRUCIFORM TIPS HAVE BROKEN OFF AT THEIR BASE. NONE OF THESE PIECES WERE RETURNED. DOCUMENT/SPECIFICATION REVIEW: THE RETURNED DEVICE WAS MANUFACTURED IN APRIL 2009 AND IS OVER 9 YEARS OLD. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. NO NCR'S WERE GENERATED DURING PRODUCTION. 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. CANNULATED CRUCIFORM SCREWDRIVER ASSEMBLY DESIGN DRAWINGS AND CANNULATED SCREWDRIVER BLADE DESIGN DRAWING WERE REVIEWED DURING THIS INVESTIGATION. THE 314.463 CANNULATED CRUCIFORM SCREWDRIVER IS A REUSABLE INSTRUMENT ROUTINELY USED IN THE 3.0MM CANNULATED SCREWS SYSTEM. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DIMENSIONAL INSPECTION: THE INSIDE DIAMETER OF THE RETURNED CANNULATED SCREWDRIVER SHAFT NEAR BREAKAGE MEASURED Ø1.23MM AT CQ (GAUGE PIN GP32) WHICH IS WITHIN SPECIFICATION OF Ø1.2MM +0.1/-0MM PER THE CANNULATED SCREWDRIVER BLADE DESIGN DRAWING. THE OUTSIDE DIAMETER OF THE RETURNED CANNULATED SCREWDRIVER SHAFT NEAR BREAKAGE MEASURED Ø3.84MM AT CQ (CALIPERS CA592) WHICH IS WITHIN SPECIFICATION OF Ø3.8MM +0.05/-0MM PER THE CANNULATED SCREWDRIVER BLADE DESIGN DRAWING. MATERIAL ANALYSIS: THE DESIGN SPECIFIED THE SHAFT COMPONENT TO BE MANUFACTURED FROM 440A STAINLESS STEEL AND HEAT TREATED PER ES0052 (50-55 HRC). THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE (55 HRC) WAS CONFIRMED TO MEET THE SPECIFICATION OF 50-55 HRC WITH NO (RELEVANT) NON-CONFORMANCE NOTED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE TIPS BREAKING OFF OF THE RETURNED 9 YEAR OLD CANNULATED SCREWDRIVER COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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.

    Description of Event or Problem · 0

    FURTHER IT WAS REPORTED THAT SURGEON USED ANOTHER SET TO COMPLETE THE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME REPORTED AS GOOD.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS SYNTHES SALES CONSULTANT. 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. 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 DURING AN UNKNOWN TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) PROCEDURE ON (B)(6) 2018, THE TIP OF THE CANNULATED CRUCIFORM SCREWDRIVER BROKE OFF. IT IS FURTHER REPORTED THE THREADS ON THE BLADE/SCREW GUIDE SLEEVE AND BUTTRESS/COMPRESSION NUT WERE BOTH BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT'S STATUS AND SURGICAL OUTCOME WERE BOTH UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620288 CANNULATED CRUCIFORM SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6113434 10886982188878

    Patients

    Seq Age Sex Outcome Treatment
    1