BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1

    MDR report key: 6883021 · Received September 21, 2017

    Report

    Report Number
    3003506883-2017-10213
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 30, 2017
    Report Date
    August 30, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    07611819393967
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART #03.114.001, SYNTHES LOT#9972971. RELEASE TO WAREHOUSE DATE: 02-MAR-2017. EXPIRATION DATE: N/A. SUPPLIER: (B)(4). NCR WAS GENERATED FOR 4 OF 29 PARTS FOR WHICH THE GO GAUGE WOULD NOT GO. ALL PARTS WERE RETURNED AND RE-SORTED DUE TO TH NON-CONFORMANCE. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: PRODUCT ISSUE WAS PREVIOUS ISSUED FOR THIS PROBLEM WITH ARTICLE 03.114.001 AND LOT 9972971 AND ESCALATED ON 08-MAY-2017 (PIE-764898) TO FIELD ACTION TEAM. INITIATED ON 17-APR-2017 BY SQE PRODUCT ISSUE ESCALATION (PIE)-INITIATED ON 08-MAY-2017 CAPA-INITIATED ON 06-JUN-2017 SCREENING NOTICE NO: 6416 STOCK HOLD NO: 2017030. PREVIOUS INVESTIGATION CONDUCTED BY MANUFACTURING PLANT MONUMENT. CAPA-ISSUED. DHR-REVIEW; NCR - WAS GENERATED FOR 4 OF 29 PARTS FOR WHICH THE GO GAUGE WOULD NOT GO. ALL PARTS WERE RETURNED AND RE-SORTED DUE TO TH NON-CONFORMANCE. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE ARE POTENTIAL 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED FOR THE VETERINARIAN SURGERY. THE SURGEON HAD A DIFFICULTY IN CONNECTING THE DRILL SLEEVE TO THE PLATE. ALTHOUGH IT WAS A REPLACED DEVICE, THE SURGEON FELT SOMETHING WRONG. THE SURGEON FELT THAT THE DEVICE INTERACTION WAS SOMEWHAT DIFFERENT. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664323 LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1 GUIDE FZX SYNTHES MONUMENT 9972971 07611819393967

    Patients

    Seq Age Sex Outcome Treatment
    1