BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREPHINE ATTACHMENT 7.0MM DIAMETER

    MDR report key: 6707613 · Received July 12, 2017

    Report

    Report Number
    9612488-2017-10304
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 13, 2017
    Report Date
    June 13, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWK
    UDI-DI
    10886982072252
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. ONE TREPHINE ATTACHMENT WAS RETURNED WITH COMPLAINT CATEGORY "BROKEN: INTRAOPERATIVELY". THIS COMPLAINT IS CONFIRMED. ONE OF THE FIVE CUTTING TEETH HAS SHEARED OFF AT ITS BASE AND WAS NOT RETURNED. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE IS ALREADY BROKEN. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. RELEVANT DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS INSTRUMENT IS IN THE ORTHOPEDIC FOOT INSTRUMENTS SYSTEM USED FOR RECONSTRUCTIVE ORTHOPEDIC FOOT SURGERY AND PROPER USE IS ADDRESSED IN RELEVANT TECHNIQUE GUIDE. THE ROOT CAUSE IS MOST LIKELY DUE TO EXCESSIVELY HARD BONE OR EXCESSIVE FORCE. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    PATIENT ID, DATE OF BIRTH AND WEIGHT WERE NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.111.026, LOT# 9160075. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 03, 2014. 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. THE DEVICE WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORT THAT THE PATIENT UNDERWENT ORIGINAL SURGERY ON (B)(6) 2017 WERE THE PATIENT PRESENTED WITH A LISFRANC INJURY. A RIGHT FOOT FUSION AT THE FIRST AND SECOND METATARSAL WAS PERFORMED. PATIENT WAS IMPLANTED WITH ONE (1) COMPRESSION FUSION PLATE, 4 CORTICAL SCREWS IN THE PLATE, THREE (3) INDEPENDENT CORTICAL SCREWS THAT WERE PLACED DIRECTLY INTO THE MIDFOOT BONE AND HARVESTED BONE GRAFT FROM THE PATIENT¿S MEDIAL DISTAL TIBIA BONE. DURING THE PROCEDURE, WHILE THE SURGEON WAS USING THE TREPHINE ATTACHMENT INSTRUMENT FOR BONE HARVESTING, ONE OF THE CUTTING TIPS ON THE GRAPH TUBE ATTACHMENT BROKE OFF AND BECAME EMBEDDED IN THE PATIENT¿S BONE. SURGEON CONTINUED USING THE SAME INSTRUMENT FOR BONE HARVESTING. THE REPORTED FRAGMENT IS APPROXIMATELY 2MM BY 2MM SQUARE. SURGEON WAS AWARE THE FRAGMENT WAS EMBEDDED AND CHOSE TO LEAVE IT IN PLACE. ADDITIONAL IMAGES WERE TAKEN TO IDENTIFY THE PLACEMENT OF THE FRAGMENT. ALSO, IT WAS REPORTED THAT AFTER THE PLATE, AND 2 OF THE CORTICAL SCREWS WERE IMPLANTED, THE COMPRESSION FORCEPS WERE USED. AS THE SURGEON WAS USING THE FORCEPS, IS WAS REPORTED THAT THE SPRING INSIDE THE INSTRUMENT HAD DETACHED FROM THE HANDLE. NO FRAGMENTS WERE GENERATED. SURGEON CHOSE OTHER FORCEPS THAT WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT WAS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) TREPHINE ATTACHMENT 7.0MM DIAMETER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488740 TREPHINE ATTACHMENT 7.0MM DIAMETER TREPHINE HWK SYNTHES BETTLACH 9160075 10886982072252

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention