BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 5783865 · Received July 11, 2016

    Report

    Report Number
    2520274-2016-13417
    Event Type
    Injury
    Date Received
    July 11, 2016
    Date of Event
    June 27, 2016
    Report Date
    June 27, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE PART FAMILY IDENTIFIED IN THE INVESTIGATION, THE FOLLOWING PART DATA IS LIKELY: PART RANGE 214.520 THROUGH 214.580 4.5MM CANNULATED SCREW PARTIALLY THREADED (20-80MM) / HWC: SCREW, FIXATION, BONE / K963172. PRODUCT INVESTIGATION SUMMARY: THIS COMPLAINT IS CONFIRMED AS THE RECEIVED SCREW'S DISTAL THREAD HAS PEELED / SHEARED OFF. THE EXACT PART NUMBER FOR THE RETURNED SCREW COULD NOT BE DEFINITIVELY DETERMINED BECAUSE THE DISTAL THREAD HAS PEELED / SHEARED OFF; THEREFORE, THE ORIGINAL LENGTH COULD NOT BE DETERMINED. HOWEVER, THE LIKELY PART FAMILY IS 4.5MM STAINLESS STEEL CANNULATED PARTIALLY THREADED SCREWS WITH PART NUMBERS RANGING FROM 214.520 THROUGH 214.580. A VISUAL INSPECTION UNDER 5X MAGNIFICATION AND A DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. THE DRAWING FOR THE 4.5MM CANNULATED SCREW WAS REVIEWED DURING THIS EVALUATION. THE SCREW WAS MADE FROM 316L STAINLESS STEEL, WHICH IS AN APPROPRIATE MATERIAL FOR AN IMPLANTABLE DEVICE OF THIS TYPE. THE 1.7MM CANNULATION IS NECESSARY TO ENABLE PASSAGE OF A 1.6MM GUIDE WIRE FOR PRECISE SCREW TARGETING FOR IMPLANTING OR EXTRACTING. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND MOST LIKELY DID NOT CONTRIBUTE TO THIS COMPLAINT. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; BUT MOST LIKELY DUE TO DENSE BONE OR INSERTION TORQUE EXCEEDING DEVICE STRENGTH. THE MANUFACTURER IS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY INSERTION INTO DENSE CORTICAL BONE OR COLLISION WITH A GUIDE WIRE OR INSERTION TORQUE EXCEEDING DEVICE STRENGTH. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. 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 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THIS REPORT IS FOR UNKNOWN UNK - SCREW CANNULATED/UNKNOWN LOT NUMBER. NOT IMPLANTED OR EXPLANTED, FRAGMENTS REMAINED IN PATIENT BONE. (B)(4). SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 THE PATIENT PRESENT WITH A DISTAL HUMOROUS FRACTURE. WHILE THE SURGEON WAS WORKING ON THE PATIENTS ELBOW BONE AND INSERTING A CANNULATED SCREW OVER THE GUIDE WIRE BY HAND, THE OUTSIDE SCREW THREADS OF THE CANNULATED SCREW CAME APART. THE REASON FOR THE FRACTURE IS UNKNOWN. THROUGH X-RAY IT WAS NOTED THAT A SMALL FRAGMENT OF THE OUTSIDE SCREW THREAD WAS LEFT IN THE PATIENT'S ELBOW BONE. SURGEON CHOSE NOT TO REMOVE THE FRAGMENT. SURGEON CHOSE ANOTHER CANNULATED SCREW FROM THE ORTHOPEDIC SCREW SET AND COMPLETED THE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL TIME ADDED. PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR 1 DEVICE. CONCOMITANT DEVICE: GUIDE WIRE- PART AND LOT NUMBER UNKNOWN, QUANTITY (B)(4) EA. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437247 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention