BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® IMPACTOR

    MDR report key: 6998323 · Received November 2, 2017

    Report

    Report Number
    1719045-2017-11132
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 7, 2017
    Report Date
    October 7, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER QUALITY (CQ) ENGINEERING INVESTIGATION: THIS COMPLAINT IS CONFIRMED. BOTH RADEL TIPS SHOW POST MANUFACTURING DAMAGE ON THEIR DISTAL TIPS IN THE FORM OF DENTS AND BROKEN OFF DISTAL CORNER FRAGMENTS THAT WERE NOT RETURNED. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICES ARE ALREADY BROKEN. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AT CQ FOR THE RETURNED DEVICE AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. IMPACTOR ASSEMBLY TOP LEVEL DRAWING AND TIP FOR IMPACTOR COMPONENT DRAWING WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. AN ACCURATE/MEANINGFUL DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AT CQ DUE TO THE POST MANUFACTURING DAMAGE. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. MOST LIKELY DUE TO OFF AXIS HAMMER STRIKES. 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

    NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 338.28 WITH LOT NUMBER(S) 4944650 IS A LOT/BATCH CONTROLLED ITEM. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 338.28, LOT# 4944650. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: MAY 05, 2005. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SERVICE AND REPAIR EVALUATION WAS COMPLETED. THE CUSTOMER REPORTED THE IMPACTOR WAS CROSS-THREADED ONTO THE BARREL AND THE TIPS WOULD NOT PROPERLY SEAT. THE REPAIR TECHNICIAN REPORTED THE TEFLON TIP WAS WORN AND A LITTLE PIECE WAS MISSING. WORN OUT PARTS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: TEFLON TIP (NEW LOT #4085248). THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, AND PASSED SYNTHES FINAL INSPECTION ON 10-NOV-2017. DUE TO THE LACK OF A PACKAGING BILL OF MATERIALS, THE REPAIRED DEVICE HAD TO BE SCRAPPED, AND A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. THE REPAIRED DEVICE 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

    (B)(4). 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 DURING AN INITIAL SURGERY, TWO SYNTHES DYNAMIC HIP SCREW/DYNAMIC CONDYLAR SCREW (DHS/DCS) SYSTEM IMPACTORS CROSS THREADED INTO THE BARREL AND THE TIPS WERE CHUNKED AND WOULD NOT PROPERLY SEAT DURING AN IMPLANT OF A DHS ON (B)(6) 2017. WHEN MALLETING THE PLATE INTO THE FEMUR, THE DHS IMPACTOR DID NOT WORK; A SECOND IMPACTOR FROM THE SET WAS OPENED AND THE SAME THING OCCURRED; THE BARREL DID NOT PROPERLY THREAD INTO THE TIP OF THE IMPACTOR AND THE IMPACTOR WAS MISSING CHUNKS FROM THE TIP AND WOULD NOT PROPERLY SEAT. THE SURGEON MANAGED TO GET THE PLATE SEATED WHICH TOOK AN EXTRA ONE (1) TO TWO (2) MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) DHS/DCS IMPACTOR THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777088 DHS®/DCS® IMPACTOR IMPACTOR HWA SYNTHES BRANDYWINE 4944650

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR