BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 8202669 · Received December 28, 2018

    Report

    Report Number
    2939274-2018-55624
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Report Date
    December 5, 2018
    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
    CO, 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, H6: PART: 319.006; SYNTHES LOT: 7972471; SUPPLIER LOT: NA; RELEASE TO WAREHOUSE DATE: APRIL 13, 2015; MANUFACTURED BY SYNTHES JENNERSVILLE. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. NO NONCONFORMANCE REPORTS (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. DEVICE EVALUATION: INVESTIGATION FLOW: BROKEN VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEPTH GAUGE PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF NEEDLE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION; AS SUCH THE COMPLAINT IS CONFIRMED. THE NEEDLE HAS BROKEN OFF AT ITS INTERFACE WITH SLIDER BODY. THE BROKEN OFF NEEDLE PORTION WAS NOT RETURNED. DIMENSIONAL INSPECTION: INSPECTION OF THE RELEVANT FEATURE, THE NEEDLE, WAS UNABLE TO BE COMPLETED AS THE SUBCOMPONENT WAS NOT RETURNED. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISIONS, WERE REVIEWED: NEEDLE DEPTH GAUGE FOR 2.0/2.4MM SCREWS DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. MATERIAL REVIEW: THE DESIGN SPECIFIES THE NEEDLE COMPONENT TO BE MANUFACTURED FROM 316L EXTRA HARD STAINLESS STEEL. DURING THE DEVICE HISTORY RECORD (DHR) REVIEW NO NONCONFORMANCES WERE NOTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. CONCLUSION A DEFINITIVE ROOT CAUSE FOR THE NEEDLE BREAKING 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. 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

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 INSPECTION AT THE STERILE PROCESSING DEPARTMENT (SPD) ON AN UNKNOWN DATE, TWO (2) DEPTH GAUGES WERE BROKEN AND HAD A MISSING WIRE; THE TIP OF THE INTERLOCK SCREWDRIVER WAS BENT; THE HANDLE OF THE STRAIGHT BALL SPIKE WAS PITTED, AND THE TWO (2) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET WOULD NOT STAY CLOSED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043941 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7972471 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1