BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS/DCS IMPACTOR (338.28)

    MDR report key: 10560155 · Received September 21, 2020

    Report

    Report Number
    2939274-2020-04219
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 24, 2020
    Report Date
    August 26, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWA
    UDI-DI
    10886982193292
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 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. VISUAL INSPECTION: THE TIP FOR DHS®/DCS® IMPACTOR (338.28) (P/N: 338.26, LOT NUMBER: 6043333) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE DISTAL TIP HAD A PIECE BROKEN OFF. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE DEVICE IS BROKEN. THE REPAIR TECHNICIAN REPORTED THE IMPACTOR IS BROKEN, SOME PIECES ARE MISSING. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION COULD BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: (CURRENT) AND(MANUFACTURED) WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DISTAL TIP IS BROKEN. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 HISTORY. PER JDE, THE DEVICE WAS RECEIVED/CREATED ON 14AUG2014. PER PROCEDURE, A DHR IS NOT REQUIRED. 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE APPLICATION OF A DYNAMIC HIP SYSTEM (DHS) FOR AN INTERTROCHANTERIC FRACTURE THE DHS COUPLING SCREW BROKE ALONG WITH THE TWO (2) TIP FOR DHS IMPACTOR. IT WAS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. ANOTHER SET WAS OPENED, AND THE ITEMS WERE PULLED FROM THE SECOND SET. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: TIP FOR DHS®/DCS® IMPACTOR (338.28) (PART NUMBER 338.26, LOT H479753, QUANTITY 1), DHS®/DCS® COUPLING SCREW (PART NUMBER 338.20, LOT 1165694, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026778 TIP FOR DHS/DCS IMPACTOR (338.28) IMPACTOR HWA WRIGHTS LANE SYNTHES USA PRODUCTS LLC 338.26 6043333 10886982193292

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR DHS®/DCS® COUPLING SCREW.| TIP FOR DHS®/DCS® IMPACTOR (338.28).| DHS®/DCS® COUPLING SCREW| TIP FOR DHS®/DCS® IMPACTOR (338.28)