BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX

    MDR report key: 6026082 · Received October 13, 2016

    Report

    Report Number
    1719045-2016-10756
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION AND PRODUCT DEVELOPMENT INVESTIGATION WERE PERFORMED FOR THE SUBJECT DEVICE. THE CANNULATED CONNECTING SCREW, (PART # 03.010.404, LOT # U210481) WAS REPORTED TO BE DIFFICULT TO REMOVE FROM THE NAIL DURING SURGERY. THE PART WAS SENT FOR A MANUFACTURING INVESTIGATION, WHICH CONCLUDED THE FOLLOWING. THE DHR FOR THE (PART # 03.010.404, LOT # U210481) WAS REVIEWED AND THERE WERE NO ISSUES OBSERVED CONCERNING THE MANUFACTURING PROCESS, NOR WERE THERE ANY DIMENSIONAL OR VISUAL/COSMETIC INSPECTION ISSUES. REVIEW OF THE DEVICE HISTORY RECORD IT WAS FOUND THAT, NCR 1114577 WAS GENERATED, HOWEVER; THE PARTS WERE RE-INSPECTED BY SUPPLIER AND FOUND TO BE CONFORMING PRIOR TO RELEASE. THE PART CONFORMS DIMENSIONALLY, BUT APPEARS TO HAVE WEAR MARKS ON THE SURFACE. THE SIGNS THAT THE PART DISPLAYS ARE INDICATIVE OF THE PART BEING CROSS THREADED TO A DIFFERENT DEVICE. IF THE DEVICE IS CROSS THREADED OR IF EXCESSIVE FORCE IS APPLIED DURING THREADING, THERE COULD BE ISSUES REMOVING THE SCREW. DURING THE PRODUCT INVESTIGATION, IT WAS FOUND THAT THE DISTAL THREADS OF THE CONNECTING SCREW ARE WORN. IT IS LIKELY THAT CROSS THREADING AND POSSIBLY THE APPLICATION OF EXCESSIVE TORQUE DURING THE ATTACHMENT OF THE CONNECTING SCREW TO THE NAIL HAVE LED TO THIS COMPLAINT CONDITION. A DRAWING WAS REVIEWED AS PART OF THE INVESTIGATION. THE DESIGN 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 ASSOCIATED NAIL WAS NOT RETURNED THEREFORE FURTHER TESTING WITH THE NAIL IN QUESTION WAS UNABLE TO BE PERFORMED. THE INTERACTION BETWEEN THE DEVICES WAS NOT ABLE TO BE DETERMINED. THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, DIMENSIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, DHR REVIEW AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THE DEVICE CAN BE REPLICATED IS NOT ABLE TO BE DETERMINED DUE TO RETURN OF ONLY 1 OF THE INVOLVED DEVICES. THE RISK ASSESSMENT ADEQUATELY ADDRESSES THE COMPLAINT EVENT. 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 DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORD REVIEW COMPLETED FOR PART # 03.010.404, LOT # U210481, RELEASE TO WAREHOUSE, DATE: NOV 04, 2014, SUPPLIER: (B)(4). ONE NON CONFORMANCE REPORT WAS GENERATED FOR NINE (9) OF SIXTY (60) PARTS FOR PART NOT ACCEPTING THE GO THREAD GAGE. PARTS WERE RE-INSPECTED BY SUPPLIER AND FOUND TO BE CONFORMING. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT INITIAL TIBIAL NAIL SURGERY. DURING THE SURGERY, THE SURGEON HAD DIFFICULTY REMOVING THE CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX DEVICE FROM THE 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 285MM-STERILE DEVICE. THE CONNECTION BOLT WAS REMOVED FROM THE NAIL AFTER A LOT OF EFFORT. THE REPORTER BELIEVES THAT THE PROBLEM WAS BECAUSE OF POSSIBLE CROSS-THREADING OF THE BOLT WHEN CONNECTING TO THE NAIL. THE NAIL WAS COUNTERSUNK BY 20MM INSIDE THE TIBIA, WHICH IS CONSIDERED DEEPER THAN USUAL. THE TIBIAL NAIL WAS LEFT INSIDE THE PATIENT. THE REPORTER BELIEVES THAT IT WAS A SUPRAPATELLA TIBIAL NAIL. THERE WERE NO FRAGMENTS OR BROKEN PIECES TO EITHER DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPORT OF ONLY A TWO MINUTE SURGICAL DELAY WITH NO MEDICAL INTERVENTION. THE PATIENT'S POST-OPERATIVE STATUS WAS NOTED TO BE STABLE. CONCOMITANT DEVICE REPORTED: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 285MM-STERILE (PART #-04.034.437S, LOT #-7922711, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676798 CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX GUIDE FZX SYNTHES MONUMENT U210481

    Patients

    Seq Age Sex Outcome Treatment
    1 PART # 04.034.437S, LOT # 7922711, QUANTITY 1