BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 6712637 · Received July 13, 2017

    Report

    Report Number
    1719045-2017-10653
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Report Date
    June 18, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. CQ INVESTIGATION PART # 314.743, LOT H193061. IT WAS REPORTED THAT TWO RIA (REAMER-IRRIGATION-ASPIRATOR) DRIVE SHAFTS WERE FOUND IN STERILE PROCESSING WITH THE ENDS BROKEN OFF. IT IS NOT KNOWN HOW OR WHEN THE ENDS BROKE OFF THE DRIVE SHAFTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE BROKEN END FRAGMENTS WERE DISCARDED AND WILL NOT BE RETURNED. BOTH DRIVE SHAFTS WILL BE RETURNED. THIS COMPLAINT INVOLVES TWO DEVICES. PART # 314.743, LOT H193061 HAS BEEN LOST OR MISPLACED BY THE HOSPITAL AND WILL NOT BE RETURNED. THE PRODUCT WAS NOT RETURNED, IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL PRODUCT CLASSIFICATION CODE: HRX. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, LOT H193061 HAS BEEN LOST OR MISPLACED BY THE HOSPITAL AND WILL NOT BE RETURNED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART #314.743, SYNTHES LOT #H193061, RELEASE TO WAREHOUSE DATE: 07-MAR-2017, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO RIA (REAMER-IRRIGATION-ASPIRATOR) DRIVE SHAFTS WERE FOUND IN STERILE PROCESSING WITH THE ENDS BROKEN OFF. IT IS NOT KNOWN HOW OR WHEN THE ENDS BROKE OFF THE DRIVE SHAFTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE BROKEN END FRAGMENTS WERE DISCARDED AND WILL NOT BE RETURNED. BOTH DRIVE SHAFTS WILL BE RETURNED. THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491742 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 314.743 H193061 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1