BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1

    MDR report key: 6598902 · Received May 30, 2017

    Report

    Report Number
    1719045-2017-10514
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    April 5, 2017
    Report Date
    April 5, 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

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED: SUPPLIER - (B)(6). PACKAGED BY : (B)(4). MANUFACTURING DATE: DEC 30, 2016; PART #: 03.114.001 LOT#: H161606 (NON-STERILE) - 1.1 MM LCP THREADED DRILL GUIDE FOR 1.5 MM LCP PLATES. QUANTITY ((B)(4)) INSPECTION SHEET FOR INCOMING FINAL INSPECTION OF COMPLIANCE RECEIVED FROM AVALIGN AND MEETS ALL SPECIFICATIONS. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE 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 PRODUCT INVESTIGATION WAS PERFORMED. THIS COMPLAINT IS CONFIRMED. THIS ISSUE HAS BEEN IDENTIFIED AND ESCALATED FROM A PREVIOUS COMPLAINT. APPROPRIATE ACTIONS HAVE BEEN TAKEN TO ADDRESS THIS ISSUE. 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

    IT WAS REPORTED THAT A LCP (LOCKING COMPRESSION PLATE) DRILL SLEEVE COULDN'T BE ATTACHED TO A PLATE. THE SURGEON DIDN'T HAVE A SURGICAL PLAN BUT HE CHECKED FOR JUST IN CASE. UNKNOWN IF PATIENT WAS INVOLVED. NO INFORMATION AVAILABLE ABOUT PATIENT AND SURGICAL OUTCOME. THERE WAS NO SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION RECEIVED, THAT THERE WAS A SECOND DRILL SLEEVE INVOLVED WITH THE SAME MALFUNCTION. 1X DRILL SLEEVE, PART #03.114.001/LOT: #H161606 UPDATED FROM CONCOMITANT DEVICE TO PART DATA: CONCOMITANT DEVICE: 1X UNK PLATE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379985 LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1 GUIDE FZX SYNTHES MONUMENT H161606 07611819393967

    Patients

    Seq Age Sex Outcome Treatment
    1