BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    MDR report key: 6802012 · Received August 17, 2017

    Report

    Report Number
    2530088-2017-10251
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Report Date
    July 26, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWA
    UDI-DI
    10886982193292
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 338.26 WITH LOT NUMBER(S) 4152302 IS A LOT/ BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 03-OCT-2000. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    PART 338.26/338.26BW, LOT 4152302: RELEASE TO WAREHOUSE DATE: SEPTEMBER 27, 2000. MANUFACTURED BY SYNTHES (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DEVICE WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE TIP OF THE DEVICE WAS BROKEN AND PIECES WERE 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 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

    A PRODUCT INVESTIGATION WAS PERFORMED. THE FOLLOWING INSTRUMENT WAS RECEIVED, 338.26, LOT 4152302. A DEVICE INSPECTION, SERVICE AND REPAIR REVIEW, DEVICE HISTORY REVIEW (DHR) AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE 338.26 SYNTHES TIP FOR DHS/DCP IMPACTOR IS CONTAINED IN THE DHS/DCS BASIC SET 105.831 AND BASIC SET 105.31. VISUAL INSPECTION OF THE 338.26 CONFIRMED THE IMPACTOR TIP IS CHIPPED AND BROKEN. RELEVANT DRAWING WAS REVIEWED AND IT SHOWS THE IMPACTOR SECTION WITH A CUT OUT. THE ACTUAL PART IS MISSING 1 SIDE AND IS CRACKED THUS CONFORMING THIS COMPLAINT. IT IS SUSPECT THAT OVER HAMMERING OF THE IMPACTOR CONTRIBUTED TO THE BREAKAGE OF THE IMPACTOR DISTAL TIP. THIS IS ALSO NORMAL WEAR AND TEAR FOR A DEVICE THAT HAS BEEN IN THE FIELD FOR 17 YEARS. DURING THE INVESTIGATION, NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. SERVICE HISTORY REVIEW (SHR) 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 A TIP FOR DYNAMIC COMPRESSION SCREW/DYNAMIC HIP SCREW (DCS/DHS) IMPACTOR WAS BROKEN. THIS WAS NOTICED DURING ROUTINE EQUIPMENT INSPECTION. THERE IS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580376 TIP FOR DHS®/DCS® IMPACTOR (338.28) IMPACTOR HWA SYNTHES BRANDYWINE 4152302 10886982193292

    Patients

    Seq Age Sex Outcome Treatment
    1