BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING SCREWDRIVER HANDLE

    MDR report key: 4643422 · Received March 31, 2015

    Report

    Report Number
    2520274-2015-12387
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Report Date
    March 17, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    OVE
    PMA / PMN Number
    PK112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. 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

    (B)(4): SUBJECT DEVICE HAS BEEN RECEIVED AND A SERVICE HISTORY MAINTENANCE REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: THE CUSTOMER REPORTED THE ITEM HAD A CHUNK BREAK OFF. THE REPAIR TECHNICIAN REPORTED THE HOUSING WAS BROKEN. HOUSING/CASING DAMAGED IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON 8-APR-2015. 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

    SERVICE HISTORY REVIEW: LOT T964635: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: TWO OF THE RATCHETING SCREWDRIVER HANDLE (PART 311.023 LOT T964635 / MANUFACTURE DATE: AUGUST 2011) WERE RECEIVED. THE RETURNED DEVICES SHOW REGULAR USE DURING THEIR 3.5+ YEAR LIFESPAN. THE BLACK HANDLE IS BROKEN OFF PROXIMAL TO THE COUPLING AND SLIDER SWITCH. THE SLIDING BUTTON ACTUATES AS DESIGNED. THE CAUSE OF THE COMPLAINT CONDITION IS UNKNOWN. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RELEVANT DRAWING FOR THE DEVICE(S) WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. PROPER USE AND MAINTENANCE FOR THE DEVICE(S) ARE ADDRESSED IN NUMEROUS TECHNIQUE GUIDES. 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

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT A CHUNK BROKE OFF OF THE HANDLE OF EACH OF TWO RATCHETS. ISSUE FOUND DURING TESTING AND AFTER WASH. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT AND THAT THE ISSUE WAS FOUND OUTSIDE THE OPERATING ROOM. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212499 RATCHETING SCREWDRIVER HANDLE INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES TUTTLINGEN T964635

    Patients

    Seq Age Sex Outcome Treatment
    1