BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/40MM

    MDR report key: 6140947 · Received December 2, 2016

    Report

    Report Number
    1000562954-2016-10221
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    November 10, 2016
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    KWQ
    PMA / PMN Number
    K925351
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DATE OF EVENT IS UNKNOWN. DATE OF IMPLANT IS UNKNOWN. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. PART NUMBER: 406.040, SYNTHES LOT NUMBER: 9179603: RELEASE TO WAREHOUSE DATE: OCT 3, 2014. MFG. SITE: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/40MM), PART NUMBER 406.040, LOT NUMBER 9179603. THE SUBJECT DEVICES WERE RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING THAT THE TWO (2) BROKEN SCREWS RETURNED IN A MINIGRIP. THE TIP PORTIONS FOR BOTH SCREW IS MISSING. THE REFERENCE NUMBERS ETCHED ON THE SCREW HEAD MATCH WITH THE DATA REPORTED IN THE SYSTEM. PART NUMBER 406.040 LOT 9179603 AND PART NUMBER 406.045 LOT 9170157 INSPECTED FOR THE FEATURES PERTINENT WITH THE COMPLAINT CONDITION (BREAKAGE OF THE SCREWS). BOTH SCREWS BROKE IN THE THREAD PORTION CLOSE TO THE TIP. THE CORE DIAMETER, THREAD DIAMETER AND THE THREAD PROFILE MEASURED IN THE AREA CLOSED TO THE BREAKAGE WERE FOUND WITHIN SPECIFICATION. IT WAS CONCLUDED THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION AND NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED ON RETURNED ITEM, THE RETURNED PART IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/40MM), PART NUMBER 406.040, LOT NUMBER 9179603. THE SUBJECT DEVICES WERE RETURNED WITH THE COMPLAINT CONDITION STATING THAT THE RECEIVED CONDITION OF SCREW 406.040 / LOT 9179603 SHOWS THAT THE THREADED SHAFT OF THE CANCELLOUS SCREW IS BROKEN IN HALF. THE BROKEN OFF PORTION WITH A LENGTH OF APPROXIMATELY 25 MM IS NOT AVAILABLE FOR INVESTIGATION. THE REMAINING THREADS ARE ROUNDED AND WORN. THE HEXAGON SOCKET IN THE SCREW HEAD SHOWS WEAR AND DAMAGE OF MECHANICAL OVERLOADING. FOR PART NUMBER 406.045 / LOT 9170157 THE RECEIVED CONDITION OF SCREW SHOWS THAT THE THREADED SHAFT OF THE CANCELLOUS SCREW IS BROKEN IN HALF. THE BROKEN OFF PORTION WITH A LENGTH OF APPROXIMATELY 23 MM IS NOT AVAILABLE FOR INVESTIGATION. THE REMAINING THREADS ARE ROUNDED AND WORN. THE HEXAGON SOCKET IN THE SCREW HEAD SHOWS WEAR OF MECHANICAL OVERLOADING. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS IN BROKEN AND/OR WORN AREAS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE MEASURABLE DIMENSIONS OF INTACT AREAS WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE VALID TECHNICAL DRAWINGS. ALL DAMAGE WAS CAUSED POST-MANUFACTURING AS THE ANODIZED GOLDEN COLOUR HAS DISAPPEARED IN ALL WORN AND DAMAGED AREAS. ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATIONS AND NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED. THE DEVICE HISTORY REVIEW (DHR) REVIEW DID NOT SHOW ANY DEVIATIONS FROM VALID SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE EXACT ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED BUT THE MOST PROBABLE REASON IS MECHANICAL OVERLOADING. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016 DUE TO TWO BROKEN SCREWS; 4.0MM TITANIUM CANCELLOUS BONE SCREW FULLY THREADED. THE SCREWS BROKE POSTOPERATIVELY ON AN UNKNOWN DATE. DURING THE REVISION SURGERY, THE BROKEN SCREWS WERE REMOVED. HOWEVER, A FRAGMENT COULD NOT BE REMOVED, EVEN WITH ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY OR PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE IMPLANT SURGERY OCCURRED ON AN UNKNOWN DATE. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791716 4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/40MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES MEZZOVICO 9179603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention