BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.76MM DRILL BIT/STRYKER J-LATCH/WITH 5MM STOP/44.5MM

    MDR report key: 6110573 · Received November 17, 2016

    Report

    Report Number
    1719045-2016-10835
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Report Date
    October 10, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZI
    PMA / PMN Number
    K043310
    Removal / Correction Number
    3008812560-11/14/2016-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT REPORTED. DATE OF THE EVENT IS UNKNOWN. THE ISSUE WAS DISCOVERED ON (B)(6) 2016. ADDITIONAL DEVICE PRODUCT CODE USED: ERL AND HBE. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 316.15, LOT # U172728. RELEASE TO WAREHOUSE DATE: AUG 29, 2013, SUPPLIER: (B)(4). NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    TWO DRILL BITS (PART # 03.503.246, LOT #'S U234081 AND U160311) AND ONE EMPTY, OPENED PRODUCT PACKAGE (PART # 316.15, LOT # U172728) WERE RECEIVED FOR INVESTIGATION. THE DRILL BITS WERE INSPECTED AND FOUND TO BE CONFORMING TO SPECIFICATIONS. THE PACKAGE IS OPENED AND IT WAS UNABLE TO BE CONFIRMED THAT AN INCORRECT DEVICE WAS RECEIVED IN THE PACKAGE. THE EXACT CAUSE OF THE COMPLAINT CONDITION WAS UNABLE TO BE CONFIRMED. FIELD ACTION INVESTIGATION HAS BEEN OPENED TO INVESTIGATE THE MATTER FURTHER AND ADDRESS THE RISK ASSOCIATED WITH THE REPORTED COMPLAINT CONDITION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 03.503.246, LOT # U160311. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: NOV 29, 2012. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 ON (B)(6) 2016 WHILE RESTOCKING THE SET, HOSPITAL CONTACT OPENED THE 0.76MM DRILL BIT PACKAGE AND NOTICED THAT THE DEVICE INSIDE THE PACKAGE WAS MATRIX 1.1MM DRILL BIT. THE LOT NUMBER ON THE PACKAGE AND ON THE 1.1 MM DRILL BIT DID NOT MATCH. AT THAT TIME HOSPITAL CONTACT ALSO CHECKED THE TWO (2) OPENED DRILL BITS IN THE SET (ONE OF WHICH WAS USED DURING SURGERY - CAPTURED UNDER COMPLAINT (B)(4) - AND THE SECOND ONE WAS IN THE SET) AND NOTICED THAT THE PART NUMBER ON BOTH THE DRILL BITS WERE MATRIX 1.1MM DRILL BIT. AT THAT TIME IT WAS CONFIRMED THAT THESE DRILL BITS ALSO CAME OUT OF A 0.76MM DRILL BIT PACKAGE. THE LOT NUMBERS ON THE PACKAGES OF THESE TWO (2) DEVICES ARE NOT AVAILABLE AS THE PACKAGES WERE DISCARDED BY HOSPITAL PERSONNEL DURING SURGERY. NO PATIENT AND CASE INVOLVEMENT REPORTED. THIS COMPLAINT WILL ADDRESS THE TWO DRILL BITS WHICH WERE IDENTIFIED AS HAVING PACKAGING ISSUES DAY AFTER THE SURGERY. COMPLAINT FOR DRILL BIT USED DURING SURGERY ON (B)(6) 2016 IS CAPTURED UNDER (B)(4). THIS REPORT IS FOR ONE (1) 0.76MM DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761001 0.76MM DRILL BIT/STRYKER J-LATCH/WITH 5MM STOP/44.5MM DRILL, BONE, POWERED DZI SYNTHES MONUMENT U160311

    Patients

    Seq Age Sex Outcome Treatment
    1