BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 6223766 · Received January 4, 2017

    Report

    Report Number
    1719045-2017-10005
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Report Date
    December 13, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTJ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A SERVICE HISTORY EVALUATION/REVIEW WAS ATTEMPTED AND CONCLUDED THAT, NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 319.006 WITH LOT NUMBER(S) 9841070 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 24-JUN-2015. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND A DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART#: 319.006, LOT#: 9841070. RELEASE TO WAREHOUSE DATE: 24JUN2015. MANUFACTURED BY SYNTHES (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A SERVICE & REPAIR EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT THE CUSTOMER REPORTED THE DEPTH GAUGE TIP SNAPPED OFF FROM THE BODY. THE REPAIR TECHNICIAN REPORTED THE TIP WAS BROKEN. TIP BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE SUBJECT DEVICE (DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS, PART # 319.006, LOT # 9841070). THE COMPLAINT CONDITION IS CONFIRMED AS THE DEPTH GAUGE WAS RECEIVED WITH THE PROXIMAL PORTION OF THE NEEDLE BROKEN OFF AT THE THREADS. THIS IS WHERE IT CONNECTS TO THE CALIBRATED BODY OF THE DEVICE. THE DISTAL PORTION OF THE NEEDLE COMPONENT WAS NOT RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THIS DEPTH GAUGE IS USED FOR MEASURING 2.0MM AND 2.4MM SCREWS IN VARIOUS TRAUMA (INCLUDING VETERINARY) PLATING SYSTEMS. IT IS LISTED IN TECHNIQUES GUIDES FOR THE DISTAL RADIUS, DISTAL ULNA, ELBOW SYSTEM, FOREFOOT/MIDFOOT, DISTAL FIBULA, DISTAL HUMERUS, CLAVICLE, ROTATION CORRECTION PLATE SYSTEM AND VET MINI FRAGMENT SYSTEM. THE DEPTH GAUGE WAS RECEIVED WITH THE PROXIMAL PORTION OF THE NEEDLE BROKEN OFF AT THE THREADS. THIS IS WHERE IT CONNECTS TO THE CALIBRATED BODY OF THE DEVICE. THE DISTAL PORTION OF THE NEEDLE COMPONENT WAS NOT RECEIVED. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND IS IN FUNCTIONAL CONDITION. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED: DEPTH GAUGE FOR 2.0/2.4MM SCREWS, NEEDLE (COMPONENT). THE SPECIFIED THICKNESS OF THE NEEDLE IS DRIVEN BY THE FACT THAT THE NEEDLE MUST FIT INTO A MINIMUM DRILLED HOLE OF APPROXIMATELY 1.5 MM. THE MATERIAL OF THE NEEDLE PROBE COMPONENT IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT COMPONENT OF THIS TYPE. THE EXACT CAUSE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED. BUT THE CONDITION OF THE DEPTH GAUGE IS CONSISTENT WITH THE RESULT OF A BENDING FORCE APPLIED TO THE NEEDLE PORTION OF THE DEPTH GAUGE THAT IS BEYOND THE YIELD LIMIT OF THE MATERIAL. THERE IS A PROTECTION SLEEVE TO PROTECT THE NEEDLE DURING TRANSPORT; AND THE OUTER BODY ADDS ADDITIONAL PROTECTION TO THE NEEDLE ATTACHMENT POINT DURING USE. 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

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT A DEPTH GAUGE TIP WAS NOTICED TO BE SNAPPED FROM THE ACTUAL BODY OF THE DEPTH GAUGE. THE MALFUNCTION WAS FOUND WHEN CONSULTANT WAS ASSEMBLING THE SET TOGETHER AND WAS UNABLE TO LOCATE THE MISSING TIP. THERE WAS NO PATIENT INVOLVEMENT AND THE EVENT OCCURRED OUTSIDE OF THE OPERATING ROOM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4469 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ SYNTHES MONUMENT 9841070 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1