BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KWQ

    MDR report key: 9262449 · Received October 31, 2019

    Report

    Report Number
    2939274-2019-61876
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Report Date
    October 21, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. UNKNOWN ROD WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE RECEIVED ROD WAS BROKEN INTO MULTIPLE PIECES. ONLY ONE BROKEN PIECE WAS RECEIVED AT CQ WITHOUT ANY TRACE OF PART AND LOT NUMBER. THE RECEIVED ROD IS LIGHT BLUE IN COLOR. THE SURFACE OF THE DEVICE SHOWS NORMAL SURFACE WEAR WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THE FRACTURE SURFACES APPEAR HOMOGENOUS WITHOUT ANY VOIDS OR DARK SPOTS. THUS, THE COMPLAINT IS BEING CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED ROD WAS PERFORMED AT CQ. THE DIAMETER OF THE DEVICE WAS MEASURED TO BE WITHIN SPECIFICATION AS PER THE DRAWING. AFTER VISUAL AND DIMENSIONAL INSPECTION, IT IS DETERMINED THAT THE POTENTIAL PART NUMBER OF THE RECEIVED DEVICE IS 498.2XX FROM FAMILY, DEGENERATIVE AND DEFORMITY RODS. SPECIFIC LENGTH OF THE COMPLAINT DEVICE WAS NOT DETERMINED. DOCUMENT/ SPECIFICATION REVIEW: THE FOLLOWING RELEVANT DRAWINGS WERE REVIEWED DURING INVESTIGATION: -STAB 6*L NO DESIGN ISSUES WERE FOUND WHICH CAN CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION CONCLUSION: A VISUAL INSPECTION, DOCUMENT/SPECIFICATION REVIEW, AND DIMENSIONAL INSPECTION WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS BEING CONFIRMED AS THE DEVICE WAS FOUND TO BE BROKEN INTO MULTIPLE PIECES. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED, AND NO NEW MALFUNCTIONS WERE IDENTIFIED EITHER. 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 · 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6 INVESTIGATION SUMMARY (UPDATED): THE UNK ROD WAS RECEIVED AT US CQ. THE ROD WAS BLUE IN COLOR AND ONLY 53.62MM OF THE ROD WAS RETURNED. NO PART # AND LOT # ETCHES WERE VISIBLE. NO OTHER PORTION WAS RETURNED. THE TIPS OF THE RETURNED ROD¿S CROSS-SECTION SHOWED EVIDENCE THAT THE ROD WAS CUT INTO MULTIPLE PIECES AND NOT BROKEN. THE OBSERVED STRESS MARKS AT THE CROSS-SECTIONS WERE CONSISTENT WITH THE ROD BEING CUT BY A TOOL AS THE STRESS MARKS INDICATE A HEAVY FORCE WAS APPLIED TO THE TWO SIDES OF THE ROD. THE USE OF A CUTTING TOOL WOULD YIELD A SIMILAR STRESS PATTERN. MOREOVER, THE CUT CROSS-SECTION WAS VERY FLAT, THERE WAS NO EVIDENCE OF CONCAVITY OR SURFACE DEVIATION WHICH WOULD BE EXPECTED OF ROD BREAKAGE/FRACTURE. IT IS NORMAL PROCEDURE TO CUT/SIZE/SHAPE THE RODS BASED ON PATIENT NEEDS. THE RETURNED ROD IS CONSISTENT WITH A CUT ROD, NOT A BROKEN ROD. THE OVERALL COMPLAINT IS NOT CONFIRMED. DEVICE FAILURE/DEFECT IDENTIFIED? NO; BASED ON THE SURFACE CONDITION AT THE SITE OF MATERIAL SEPARATION, THE ROD WAS CUT AND NOT BROKEN. DIMENSIONAL INSPECTION: AFTER VISUAL INSPECTION, IT IS DETERMINED THAT THE POTENTIAL PART NUMBER OF THE RECEIVED DEVICE IS 498.2XX FROM FAMILY, DEGENERATIVE AND DEFORMITY RODS. SPECIFIC LENGTH OF THE COMPLAINT DEVICE WAS NOT DETERMINED. SPECIFIED DIMENSIONS: ROD DIAMETER= 6.00 + 0.0MM / - 0.048MM. MEASURED DIMENSIONS: ROD DIAMETER= 5.967MM; CONFORMING (MEASURED W/ OM147). CONCLUSION: THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR THE RECEIVED UNK ROD AS THE ROD WAS CUT AND NOT BROKEN AS EVIDENCED BY THE OBSERVED STRESS AND THE FLAT-CROSS SECTION. 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 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.

    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. THE DEVICE WAS 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

    510K: THIS REPORT IS FOR AN UNKNOWN ROD/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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) 2019, A TITANIUM (TI) HARD ROD WAS NOTED TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNK - RODS. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058015 KWQ ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1