BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER

    MDR report key: 8116709 · Received November 29, 2018

    Report

    Report Number
    2939274-2018-55156
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Report Date
    November 13, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982271075
    PMA / PMN Number
    K172157
    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. DEVICE HISTORY PART: 03.033.003, LOT: L963559, MANUFACTURING SITE: HAEGENDORF, RELEASE TO WAREHOUSE DATE: 27.SEP.2018. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS.ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. DEVICE HISTORY BATCH, DEVICE HISTORY REVIEW NULL INVESTIGATION SUMMARY BACKGROUND: IT WAS REPORTED THAT THAT ON AN UNKNOWN DATE, A REPLACEMENT RADIOLUCENT AIMING ARM - GREATER TROCHANTER (03.033.003, L963559) WAS DISCOVERED TO HAVE A BROKEN DRILL SLEEVE LOCKING MECHANISM UPON OPENING THE ENVELOPE. THERE WAS NO PATIENT INVOLVEMENT. DEVICE EVALUATION: INVESTIGATION FLOW: BROKEN. VISUAL INSPECTION: UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE RADIOLUCENT AIMING ARM FOR THE GREATER TROCHANTER WAS SEALED IN ITS NON-STERILE, CLEAR PLASTIC PACKAGING WHICH WAS WITHIN A CARDBOARD SHIPPING ENVELOPE BUT THE ONE OF THE CAM LOCKS FOR RDL AIMING ARM WAS FOUND TO BE BROKEN. NO OTHER DAMAGE WAS NOTED TO THE RADIOLUCENT AIMING ARM FOR THE GREATER TROCHANTER. NO SURFACE WEAR WAS NOTED, CONSISTENT WITH THE USAGE, OR LACK THEREOF, OF THE DEVICE. THE RECEIVED CONDITION WAS DETERMINED TO AGREE WITH THE COMPLAINT DESCRIPTION AND THEREFORE THE COMPLAINT IS CONFIRMED. DIMENSIONAL INSPECTION: DUE TO POST-MANUFACTURING DEFORMATION, DIMENSIONAL INSPECTION COULD NOT BE CONDUCTED. DOCUMENT/SPECIFICATION REVIEW: DURING THE DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. AIMING ARM- ASM ¿ GREATER TROCHANTER : CAM LOCK FOR RDL AIMING ARM. 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. THE MATERIAL WAS REVIEWED, AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. THE CAUSE OF THE COMPLAINT CONDITION CAN BE DEDUCED TO BE DUE TO PACKAGING DISTRIBUTION. AS THE DEVICE WAS A WARRANTY REPLACEMENT AND SHIPPED AND PACKAGED INDIVIDUALLY, ARRIVING BROKEN, IT CAN BE ASSUMED THAT THE DAMAGE WAS INCURRED DURING THE DISTRIBUTION OF THE PACKAGE. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED AND NO NEW PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. BASED UPON THE INVESTIGATION FINDINGS, NO ADDITIONAL CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS THE COMPLAINT CONDITION WAS DEDUCED TO BE DUE TO PACKAGING DISTRIBUTION. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: REPORTER IS SYNTHES SALES CONSULTANT. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ARM OF THE RADIOLUCENT AIMING ARM FOR GREATER TROCHANTER WAS DISCOVERED TO HAVE A BROKEN DRILL SLEEVE LOCKING MECHANISM UPON OPENING THE ENVELOPE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVED ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957115 RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.033.003 L963559 10886982271075

    Patients

    Seq Age Sex Outcome Treatment
    1