BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS

    MDR report key: 11399883 · Received March 2, 2021

    Report

    Report Number
    2939274-2021-01124
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    February 8, 2021
    Report Date
    February 8, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982190314
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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. CUSTOMER QUALITY INVESTIGATION: THE INSTRUMENT(S) WAS NOT RETURNED, AND THE INVESTIGATION WILL BE COMPLETED BASED ON THE SUPPLIED IMAGE(S).THE IMAGE(S) WAS REVIEWED, AND THERE IS SOME NICKS ON THE INSTRUMENT, HOWEVER IT WOULD NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. THERE IS NO INDICATION THE MEASUREMENTS OF THE DEPTH GAUGE ARE OFF AS THE COMPARISON OF THE TWO GAUGES ARE NOT PERFECTLY LINED UP TO MAKE AN ACCURATE CONCLUSION AND THEREFORE IS UNCONFIRMED. AS THE INSTRUMENTS) WAS NOT RETURNED AN AS RECEIVED, DIMENSIONAL, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS PART/LOT COMBINATION ARE UNKNOWN AT SYNTHES GMBH, NO DHR REVIEW POSSIBLE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT AS IT WAS UNCONFIRMED. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION (BASED ON THE IMAGES) 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 HISTORY LOT: PART/LOT COMBINATION ARE UNKNOWN AT SYNTHES GMBH, NO DHR REVIEW POSSIBLE. 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. VISUAL INSPECTION: CANN SCR MEASURE DV 6.5 & 7.3 CANN SCRS (PART# 319.70, LOT# A4DF803, QTY# 1) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE DEVICE LOOKS GOOD WITHOUT ANY PHYSICAL DAMAGE. THE SURFACE OF THE DEVICE SHOWS NORMAL WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DOCUMENT(S) WAS REVIEWED: -CANN SCREW MEAS NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION (CALIPERS: CA472): DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS PERFORMED AT CUSTOMER QUALITY (CQ). THE LENGTH OF THE DEVICE IS WITHIN SPECIFICATION AS PER THE DRAWING. COMPLAINT CONFIRMED? NO INVESTIGATION CONCLUSION: THE COMPLAINT CANNOT BE CONFIRMED FOR CANN SCR MEASURE DV 6.5 & 7.3 CANN SCRS (PART# 319.70, LOT# A4DF803) AS NO DEFECTS WERE IDENTIFIED WITH THE RETURNED DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 · 1

    PATIENT IDENTIFIER: (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(6) 2021, 2 CANNULATED SCREWS WERE PUT INTO A PATIENT¿S ANKLE AND WERE BE TOO LONG. WHEN TWO DEPTH GAUGES WERE COMPARED, IT WAS DETERMINED THAT THE DEPTH GAUGE IN QUESTION, WAS OFF AT LEAST 5MM. THE SCREWS WERE EXCHANGED, AND SURGERY SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THE SURGERY WAS DELAYED FOR 5 MINUTES. CONCOMITANT DEVICES REPORTED: 6.5MM CANNULATED SCREW FULLY THREADED 75MM (PART NUMBER 208.471, LOT UNKNOWN, QUANTITY 1). 6.5MM CANNULATED SCREW FULLY THREADED 80MM (PART NUMBER 208.472, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298886 CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.70 A4DF803 10886982190314

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR 6.5MM CANNULATED SCREW FULLY THREADED 75MM| 6.5MM CANNULATED SCREW FULLY THREADED 80MM