BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION BOLT FOR 2.0MM SCREWS

    MDR report key: 6757588 · Received August 1, 2017

    Report

    Report Number
    9612488-2017-10377
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Date of Event
    July 2, 2017
    Report Date
    July 5, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWB
    UDI-DI
    10886982185662
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PATIENT GENDER WAS NOT PROVIDED FOR REPORTING. 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

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 309.190, LOT# 2802554. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: DEC 19, 2011. 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. 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 2 OF 3, PART # 309.190, LOT # 2802554, EXTRACTION BOLT FOR 2.0MM SCREWS. VISUAL INSPECTION: THIS COMPLAINT IS CONFIRMED. THE MOST DISTAL 0.5MM (CALIPERS CA592) IS SHEARED OFF THE RETURNED BOLT. NO MEANINGFUL MEASUREMENTS COULD BE OBTAINED FOR PERTINENT FEATURES RELEVANT TO THIS COMPLAINT DUE TO THE DAMAGE. DRAWING REVIEW: DRAWING MADE TO REVISION 03 AND CURRENT DRAWING, REVISION A WERE 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID, DOB, AND WEIGHT NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS CURRENTLY UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE HISTORY RECORDS REVIEW WAS REQUESTED. 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

    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 IS REPORT 2 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL SURGERY FOR A PEDIATRIC ELBOW FRACTURE OF THE MEDIAL EPICONDYLE, 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 A 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 30 MINUTE SURGICAL DELAY. THE SURGEON SUCCESSFULLY COMPLETED SURGERY AND IMPLANTED A 3.0 CANNULATED SCREWS IN A NEW LOCATION AROUND THE REMAINING (BROKEN) SCREW TIP. PATIENT IS REPORTED AS OKAY. THIS COMPLAINT INVOLVES "THREE (2)" DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538754 EXTRACTION BOLT FOR 2.0MM SCREWS EXTRACTOR HWB SYNTHES BETTLACH 2802554 10886982185662

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR