BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SPREADER 12MM BEAK WIDTH

    MDR report key: 5606388 · Received April 25, 2016

    Report

    Report Number
    3009417901-2016-10015
    Event Type
    Malfunction
    Date Received
    April 25, 2016
    Report Date
    April 6, 2016
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HWN
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 399.13 WITH LOT NUMBER(S) 5904158 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS FEBRUARY 24, 2010. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE ONE OF THE SPRINGS WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE PRELOAD LEAF SPRING WAS BROKEN, AND THE PART WAS NOT AVAILABLE. LEAF/SPRING BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 INVESTIGATION SUMMARY: ONE (1) BONE SPREADER 12MM BEAK WIDTH (PART 399.130 / LOT 5904158) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKEN: PROCEDURAL STEP UNKNOWN." THIS COMPLAINT IS CONFIRMED AS THE DEVICE WAS RECEIVED WITH THE MALE LEAF SPRING SHEARED OFF APPROXIMATELY 8MM FROM WHERE IT IS SECURED TO THE HANDLE WITH A SCREW. THE SHEARED OFF MALE LEAF SPRING WAS NOT RETURNED FOR EVALUATION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS DETAILS PERTAINING TO THE METHOD OF USE AT THE TIME OF FAILURE WERE NOT AVAILABLE; THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE PRESSURE. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE DEVICE WENT THROUGH THE SERVICE & REPAIR PROCESS, BUT WAS UNABLE TO BE REPAIRED. THE BONE SPREADER IS NOTED IN THREE (3) SPINE SYSTEM TECHNIQUE GUIDES: VEPTR, VEPTR II, AND T-PLIF MINIMALLY INVASIVE AND AUXILIARY INSTRUMENTS. THE DEVICE IT UTILIZED FOR CHEST WALL DISTRACTION OR INTERVERTEBRAL DISC SPACE DISTRACTION. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED: TOP-LEVEL AND MALE LEAF SPRING. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 AFTER STERILIZATION IT WAS NOTICED THAT ONE OF THE SPRING TINES OF THE BONE SPREADER INSTRUMENT WAS BROKEN. IT IS UNKNOWN IF THE INSTRUMENT WAS BROKEN BEFORE THE STERILIZATION PROCESS. IT WAS CONFIRMED THAT THERE WAS NO PATIENT AND SURGICAL CASE INVOLVED WITH THE SUBJECT DEVICE ISSUE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261465 BONE SPREADER 12MM BEAK WIDTH INSTRUMENT COMPRESSION HWN SYNTHES SALZBURG 5904158

    Patients

    Seq Age Sex Outcome Treatment
    1