BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 8312904 · Received February 6, 2019

    Report

    Report Number
    2939274-2019-56331
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Report Date
    January 18, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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, H6: PART: 319.006; SYNTHES LOT: 4934242; RELEASE TO WAREHOUSE DATE: JANUARY 29, 2005; MANUFACTURING SITE: SYNTHES BRANDYWINE NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: VISUAL INSPECTION OBSERVED THAT THE DISTAL NEEDLE PORTION OF THE DEPTH GAUGE BROKE OFF WHERE THE THREADS OF THE NEEDLE PORTION ARE (NEEDLE COMPONENT) AND WAS RETURNED. THE BREAK IS ROUGHLY FLUSH WITH THE DEPTH GAUGE BODY. SOME SURFACE WEAR IS PRESENT BUT CONSISTENT WITH USE AND THE AGE OF THE DEVICE. THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION FOR BROKEN AND IS CONFIRMED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED TO BE USE ERROR, MISUSE/ABUSE, NONCOMPLIANCE, POSTOPERATIVE TRAUMA. SPECIFICATIONS: THREADED DISTAL TIP Ø: 1.115-1.182 MM MEASURED DIMENSIONS: Ø: 1.139 MM; CONFORMING DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWINGS WERE REVIEWED; DEPTH GAUGE FOR 2.0/2.4 MM SCREWS NEEDLE REVIEW OF THE DEVICE HISTORY RECORD(S) (DHR) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MATERIAL WAS REVIEWED, AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO RELEVANT NON-CONFORMANCE NOTED. MATERIAL/HARDNESS REVIEW: THE MATERIAL OF THE NEEDLE COMPONENT (PART # 319.006.3) IS 316LEH (L=LOW CARBON, E=EXTRA H=HARD) 316 STAINLESS STEEL (SS), WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT COMPONENT OF THIS TYPE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE MATERIAL WAS CONFIRMED TO BE CORRECT VIA THE DHR REVIEW. INVESTIGATION CONCLUSION: THE EXACT CAUSE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED AS THE HANDLING AND USE OF THE DEVICE ARE UNKNOWN. HOWEVER, THE CONDITION OF THE DEPTH GAUGE IS CONSISTENT WITH THE RESULT OF A BENDING FORCE APPLIED TO THE NEEDLE PORTION OF THE DEPTH GAUGE THAT IS BEYOND THE YIELD LIMIT OF THE MATERIAL. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. OCCUPATION: REPORTER IS SYNTHES SALES CONSULTANT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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, THE TIP OF THE NEEDLE OF THE DEPTH GAUGE WAS FOUND BROKEN IN THE SET. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105752 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4934242 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1