BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAP F/1.5MM RESORBABLE CORTEX SCR/(SLF-DRLG) 8MM MQC

    MDR report key: 5857694 · Received August 9, 2016

    Report

    Report Number
    1719045-2016-10598
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 2, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: PART/LOT CLARIFICATION: THE DEVICE WAS MANUFACTURED AS A STERILE DEVICE BY MONUMENT WITH A PART NUMBER OF 311.037.01S; HOWEVER, THE DEVICE IS ONLY AVAILABLE FOR DISTRIBUTION IN THE EU IN A NON-STERILE FORM. IT HAS BEEN CONFIRMED THAT THE SAME LOT NUMBER (5080042) IS APPLICABLE FOR THIS NON-STERILE DEVICE. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: SUPPLIER: (B)(4), PACKAGED BY: (B)(4). MANUFACTURING DATE: OCTOBER 26, 2005 -EXPIRATION DATE (FOR THE STERILE PART 311.037.01S ONLY): SEPTEMBER 30, 2014 NO NON-CONFORMANCE REPORTS 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. A REVIEW OF THE STERILITY DOCUMENTATION WAS REVIEWED AS WELL AND DETERMINED TO BE CONFORMING. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: A PIECE OF ABOUT 6MM OF THE THREADED PART ARE BROKEN OFF AND WAS NOT SENT BACK FOR EVALUATION. THE REMAINING CUTTING EDGES ARE SLIGHTLY BLUNT, BUT OTHERWISE IN GOOD CONDITION. THE MANUFACTURING DOCUMENTS OF THE RECEIVED TAP FOR RESORBABLE CORTEX SCREWS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND; THIS TAP WAS MANUFACTURED IN NOVEMBER 2005 ACCORDING TO THE SPECIFICATION. THE RELEVANT DIMENSIONS WERE AS FAR AS POSSIBLE CHECKED AND NO DEVIATION COULD BE DETECTED. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THESE FINDINGS SPEAK AGAINST ANY PRODUCT RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE AND IT IS LIKELY THAT A MECHANICAL OVERLOAD DURING USE CAUSED THIS BREAKAGE. THE DEVICE DOCUMENTATION RECOMMENDS PREDRILLING THE HOLE BEFORE TAPPING IN CASES OF DENSE, SOLID CORTICAL BONE OR IN AREAS OF EXTREME COMMINUTION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR 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

    PATIENT INFORMATION IS UNKNOWN. CATALOG NUMBER PROVIDED WAS FOR NON-STERILE PART 311.037, BUT BASED ON THE PROVIDED LOT NUMBER, PART IS MOST LIKELY THE STERILE VERSION OF THE DEVICE (CATALOG NUMBER 311.037.01S). (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE SURGEON DRILLED AND TAPPED THE SCREW PER THE TECHNIQUE GUIDE. WHEN REMOVING THE 8MM TAP, IT WAS NOTED THAT HALF OF IT HAD SNAPPED OFF IN THE PATIENT'S BONE. THE SURGEON WAS UNABLE TO RETRIEVE IT DUE TO THE DEPTH OF IT SO IT WAS LEFT IN THE PATIENT'S BONE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE PROCEDURE WAS NOT PROLONGED. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513843 TAP F/1.5MM RESORBABLE CORTEX SCR/(SLF-DRLG) 8MM MQC TAP, BONE HWX SYNTHES MONUMENT 5080042

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention