BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING, SMALL

    MDR report key: 11309005 · Received February 10, 2021

    Report

    Report Number
    2939274-2021-00753
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 20, 2021
    Report Date
    January 20, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWX
    UDI-DI
    10886982187390
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D4, LOT #. D10: CONCOMITANT DEVICE REPORTED. H3, H4, H6: DEVICE HISTORY LOT PART # 311.43. SYNTHES LOT # 4953872. SUPPLIER LOT # NA. RELEASE TO WAREHOUSE DATE: 25 FEB 2005. MANUFACTURED BY SYNTHES BRANDYWINE. MRR # 57108 WAS GENERATED DURING PRODUCTION FOR PINHOLE DAMAGE ON STAR-DRIVE SCREWDRIVER SHAFT HANDLE AND UNKNOWN BLADE STUCK TOGETHER. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: BACKGROUND: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAR-DRIVE SCREWDRIVER SHAFT HANDLE AND UNKNOWN BLADE STUCK TOGETHER. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE HANDLE WITH QUICK COUPLING, SMALL (P/N: 311.43, LOT #: 4953872) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE WAS RECEIVED ASSEMBLED WITH THE STAR DRIVE SCREWDRIVER SHAFT (P/N: 314.467). NO OTHER ISSUES WERE IDENTIFIED DURING INSPECTION. FUNCTIONAL TEST: DURING THE FUNCTIONAL TEST, AN ATTEMPT TO DISASSEMBLE BOTH THE DEVICES FAILED AS THE SCREWDRIVER SHAFT WAS STUCK INSIDE THE QUICK COUPLING HANDLE. THE SLEEVE COULD SLIDE, BUT THE SHAFT WOULD NOT RELEASE. FURTHER FUNCTIONAL ASSESSMENT OF THE INTERNAL COMPONENTS COULD NOT BE PERFORMED AS THEY WERE INACCESSIBLE DUE TO THE DISASSEMBLY ISSUE. THE SCREWDRIVER SHAFT WAS INVESTIGATED UNDER THE PI-16117045591856438. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE INTERNAL COMPONENTS WERE INACCESSIBLE WITHOUT DESTRUCTION OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED . TAP HANDLE FOR SMALL TAPS AND CSK: 311_43, REV. R/J. COMPLAINT WAS CONFIRMED. THE DEVICE RECEIVED WAS JAMMED. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION : THE COMPLAINT CONDITION IS CONFIRMED FOR THE HANDLE WITH QUICK COUPLING, SMALL (P/N: 311.43, LOT #: 4953872). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT 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. H11: D4, G1. 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. D4, G1.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J EMPLOYEE. 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 (B)(6), 2021, THE STARDRIVE SCREWDRIVER SHAFT HANDLE AND UNKNOWN BLADE STUCK TOGETHER. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING, SMALL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203831 HANDLE WITH QUICK COUPLING, SMALL TAP,BONE HWX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 311.43 4953872 10886982187390

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDLE WITH QUICK COUPLING, SMALL| STARDRIVE SCREWDRIVER SHAFT T8 105MM| STARDRIVE SCREWDRIVER SHAFT T8 105MM