BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE

    MDR report key: 6825754 · Received August 28, 2017

    Report

    Report Number
    1719045-2017-10852
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 7, 2017
    Report Date
    August 7, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    10886982067968
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, DOB & WEIGHT NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER 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. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT: PART# 03.010.146, LOT# UR83467. DHR REVIEW FOR PART #03.010.146, SYNTHES LOT #UR83467. RELEASE TO WAREHOUSE DATE: 17-DEC-2007, 19-AUG-2008. EXPIRATION DATE: N/A SUPPLIER: (B)(4). (B)(4) WAS GENERATED FOR 1 OF 4 PARTS FOR THREAD GAUGE THAT DOESN'T THREAD TO CORRECT DEPTH. PART WAS INVESTIGATED AND FOUND TO MEET REQUIREMENTS. 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. 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 DEVELOPMENT INVESTIGATION WAS PERFORMED. A VISUAL INSPECTION, DIMENSIONAL TEST, DRAWING REVIEW AND DEVICE HISTORY RECORD (DHR) REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE INSERTION HANDLE (PART# 03.008.007 LOT# 1588091) SHOWS SURFACE WEAR AND SCRATCHES CONSISTENT WITH USE. UNRELATED TO THE COMPLAINT THE ETCHING ON THE PART IS FADING. THE TABS ON THE HANDLE WHICH MATE TO THE NAIL APPEAR SLIGHTLY DEFORMED/BENT DUE TO POST MANUFACTURING DAMAGE. THE DIAMETER OF THE INSERTION HANDLE WAS MEASURED AND FOUND TO BE WITHIN THE SPECIFICATION PER RELEVANT DRAWING. THE WIDTH OF THE TABS ON THE HANDLE WERE MEASURED. THE SMALLER TAB WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION PER RELEVANT DRAWING. THE LARGER TAB WAS MEASURED AND FOUND TO BE NOT WITHIN THE SPECIFICATION PER RELEVANT DRAWING. THE RETURNED AIMING ARM (PART# 03.008.009 LOT#1908300) SHOWS EVIDENCE OF SURFACE WEAR CONSISTENT WITH USE. UNRELATED TO THE COMPLAINT THE ETCHING IS FADING. THE CANNULATED CONNECTING SCREW (PART# 03.010.146 LOT# UR83467) SHOWS EVIDENCE OF SURFACE WEAR CONSISTENT WITH USE. THE INSERTION HANDLE AND AIMING ARM ARE ABLE TO MATE TOGETHER APPROPRIATELY. THE CONNECTING SCREW FITS INSIDE THE INSERTION HANDLE; HOWEVER, THE FUNCTIONALITY/MATING BETWEEN THE DEVICES AND THE NAIL CANNOT BE FULLY TESTED BECAUSE THE NAIL WAS NOT RETURNED. THE TAB ON THE INSERTION HANDLE BEING DAMAGED AND OUT OF SPECIFICATION WOULD LIKELY LEAD TO THE MISALIGNMENT AS THIS IS THE INTERFACE WITH THE NAIL. THE AIMING ARM AND CONNECTING SCREW SHOW NO SIGNS OF CONTRIBUTING TO THE COMPLAINT CONDITION THEREFORE DIMENSIONAL INSPECTION OF THESE PARTS WILL NOT BE CONDUCTED. THE COMPLAINT IS CONFIRMED BASED ON THE DEFORMED TAB ON THE INSERTION HANDLE WHICH IS NO LONGER WITHIN SPECIFICATION. REPLICATION OF THE COMPLAINT CONDITION IS NOT POSSIBLE AS THE CONCOMITANT DEVICES WERE NOT RETURNED. IT IS UNKNOWN IF THE DEFORMED TAB CONTRIBUTED TO THE COMPLAINT CONDITION. DHR REVIEW FOR PART #03.010.146, SYNTHES LOT#UR83467: MATERIAL REVIEW REPORT (MRR) WAS GENERATED FOR 1 OF 4 PARTS FOR THREAD GAUGE THAT DOESN'T THREAD TO CORRECT DEPTH. PART WAS INVESTIGATED AND FOUND TO MEET REQUIREMENTS. THE RETURNED DEVICE SHOWS NO SIGNS OF DAMAGE TO THE THREADS DESPITE OVER 9 YEARS OF USE. THE NOTED MRR INDICATED THAT THE PART WAS INVESTIGATED AND MET REQUIREMENTS. THERE IS NO EVIDENCE THAT THE MMR IS RELATED TO THE COMPLAINT CONDITION AS ALL RELEASED PARTS MET SPECIFICATION. THE RELEVANT DRAWINGS WERE REVIEWED DURING INVESTIGATION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE DEFORMED TAB IN THE INSERTION HANDLE MOST LIKELY OCCURRED DUE TO EXCESSIVE INTRAOPERATIVE FORCES ON THE DEVICE. THE DEFORMED TAB COULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION; HOWEVER, THE COMPLAINT CONDITION COULD NOT BE REPLICATED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. 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 AN INSERTION HANDLE, AIMING ARM AND CANNULATED CONNECTING SCREW FOR PERCUTANEOUS INSERTION HANDLE WERE INSTRUMENTAL IN A SCREW NOT ALIGNING WITH A NAIL ON (B)(6) 2017. THIS MISALIGNMENT OCCURRED DURING A HINDFOOT FUSION PROCEDURE LEADING TO A MINUTE SURGICAL DELAY. AN X-RAY (UNAVAILABLE) WAS TAKEN DUE TO THE MISALIGNMENT. ANOTHER SET OF INSTRUMENTS WAS READILY AVAILABLE AND PROCEDURE WAS SUCCESSFUL WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR THREE (3) DEVICES. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1); UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). (B)(4).

    Description of Event or Problem · 1

    FURTHER IT WAS REPORTED THAT THE SURGERY WAS DELAYED FOR FIVE (5) MINUTES DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603287 CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE GUIDE FZX SYNTHES MONUMENT UR83467 10886982067968

    Patients

    Seq Age Sex Outcome Treatment
    1