BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM CANNULATED SCREW LONG THREAD/30MM

    MDR report key: 6768203 · Received August 4, 2017

    Report

    Report Number
    1719045-2017-10737
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 2, 2017
    Report Date
    July 5, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K962823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID, GENDER AND WEIGHT WERE NOT PROVIDED FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE: HTN. UDI# (B)(4) LOT# UNKNOWN. DEVICE MALFUNCTIONED INTRAOPERATIVE. DEVICE WAS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AT CQ FOR THE RETURNED COMPLAINT DEVICES, AS PART OF THIS INVESTIGATION. DEVICE 3 OF 3. PART# 202.730 LOT# UNKNOWN 3.0MM CANNULATED SCREW LONG THREAD/30MM. VISUAL INSPECTION: A PORTION OF SCREW (REPORTED AS PART# 202.730) IS LODGED INSIDE A RETURNED CONCOMITANT DEVICE PART #: 309.190 LOT #: 2025. AS THE SCREW FRAGMENT IS INACCESSIBLE, NO MEANINGFUL MEASUREMENTS COULD BE OBTAINED FOR PERTINENT FEATURES RELEVANT TO THIS COMPLAINT. DRAWING REVIEW: CANNULATED DRAWING CURRENT REVISION D FOR THE FAMILY OF 3.0MM CANNULATED LONG THREAD SCREWS WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DEVICE 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) 2017, PATIENT UNDERWENT INITIAL SURGERY FOR A PEDIATRIC ELBOW FRACTURE OF THE MEDIAL EPICONDYLE. DURING THE SURGERY, THERE WERE MULTIPLE MALFUNCTIONS. DURING IMPLANTATION OF A 3.0MM CANNULATED SCREW LONG THREAD/30MM, THE CANNULATED CRUCIFORM SCREWDRIVER TIP SNAPPED OFF. THE TIP WAS RETRIEVED. A BACK-UP SCREWDRIVER WAS AVAILABLE FOR USE AND DURING IMPLANTATION OF THE SAME CANNULATED SCREW THE SCREW BROKE IN THE MIDDLE OF THE SHAFT. THE SURGEON ATTEMPTED TO EXTRACT THE SCREW TIP, (PROXIMAL), USING AN EXTRACTION BOLT FOR 2.0MM SCREWS WHEN THE REAMER SNAPPED IN HALF. THE SURGEON LEFT THE SCREW TIP IN THE PATIENT. THE BOTTOM PORTION (DISTAL) OF THE SCREW REMAINED IN THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AS CONFIRMED BY X-RAY. MULTIPLE ADDITIONAL X-RAYS WERE TAKEN DUE TO THE MALFUNCTIONS. THERE WAS A ONE HOUR AND THIRTY MINUTES SURGICAL DELAY. THE SURGEON SUCCESSFULLY COMPLETED SURGERY AND IMPLANTED 3.0 CANNULATED SCREWS IN A NEW LOCATION AROUND THE REMAINING (BROKEN) SCREW TIP. PATIENT WAS REPORTED AS OKAY. CONCOMITANT DEVICES REPORTED: SPARE REAMER TUBE FOR HOLLOW REAMER (PART# 309.038, LOT# 2670240, QUANTITY 1). SPARE REAMER TUBE FOR HOLLOW REAMER (PART#309.280, LOT# 2028, QUANTITY 1). SPARE REAMER TUBE FOR HOLLOW REAMER (PART#309.280, LOT# 2000015, QUANTITY 1). EXTRACTION BOLT FOR 2.0MM SCREWS (PART# 309.190, LOT# 2025, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.0MM CANNULATED SCREW LONG THREAD/30MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549406 3.0MM CANNULATED SCREW LONG THREAD/30MM SCREW,FIXATION,BONE HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR