BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 8951132 · Received August 30, 2019

    Report

    Report Number
    2939274-2019-60249
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Report Date
    August 2, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    07611819739208
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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. ADDITIONAL PROCODES: NBH, HRX. 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 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 PROCODE: NBJ, HRX. MANUFACTURING LOCATION: SUPPLIER ¿ (B)(4). RELEASE TO WAREHOUSE DATE: JANUARY 14, 2019. PART: 314.743, DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. LOT: H627486 (NON-STERILE). PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE SUPPLIED BY CRITERION TOOL AND DIE WAS REVIEWED AND DETERMINED TO BE CONFORMING. NOTE: CERTIFICATE OF COMPLIANCE IDENTIFIES RAW MATERIAL TYPE(S) USED BUT DOES NOT PROVIDE ADDITIONAL CONFORMANCE / TEST REPORTS FOR SPECIFIC RAW MATERIALS. HARDNESS SPECIFICATION HRC 40-47. CERTIFIED RESULTS OF HRC 45-46. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE COUPLER DISTAL TIP OF THE DEVICE BROKEN. THE BROKEN OFF DISTAL TIP FRAGMENTS WERE NOT RECEIVED AT CQ. RUST WAS OBSERVED ON THE PROXIMAL END OF THE DRIVE ATTACHMENT. NO OTHER ISSUES WERE IDENTIFIED. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. OUTER DIAMETER OF THE DRIVE SHAFT WAS MEASURED TO BE WITHIN SPECIFICATION AS PER THE DRAWING. INNER DIAMETER OF THE DRIVE SHAFT WAS MEASURED TO BE 3 WITHIN SPECIFICATION AS PER THE DRAWING. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. DRIVE SHAFT ASSEMBLY RIA. DRIVE SHAFT RIA. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA AS THE DEVICE WAS BROKEN. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE BREAKAGE 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. 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, DURING INSPECTION OF THE INSTRUMENTS BEFORE GOING THROUGH DECONTAMINATION PROCESS, A DRIVER SHAFT FOR REAMER IRRIGATOR ASPIRATOR (RIA) WAS DAMAGED. THE TIP WAS BROKEN OFF AND A DISPOSABLE REAMER TIP CANNOT BE PUT ON THE SHAFT. THERE WAS NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. CONCOMITANT DEVICES: REAMER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A DRIVE SHAFT-MINIMUM 520MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745289 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC H627486 07611819739208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - REAMERS