BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 5990894 · Received September 30, 2016

    Report

    Report Number
    3000270450-2016-10237
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDS
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT REPORTED AS (B)(46. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES ONE CANNULATED CONNECTING SCREW, FOR PERCUTANEOUS INSTRUMENTS FOR NAILS-EX (PART 03.010.404 / LOT U210481), ONE INSERTION HANDLE, FOR SUPRAPATELLAR (PART 03.010.440 / LOT 14-6678). THE SUBJECT DEVICES WERE RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DEVICE INTERACTION: DOES NOT FIT WITH OTHER PARTS.¿ A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THESE DEVICES ARE USED TOGETHER FOR INSERTION OF THE TITANIUM CANNULATED TIBIAL ¿EX NAILS WHEN A SUPRAPATELLAR APPROACH IS DESIRED. INFORMATION IS PROVIDED PER THE SUPRAPATELLAR INSTRUMENTATION TECHNIQUE GUIDE. THE DEVICES WERE RECEIVED INTACT. DENTS WERE OBSERVED ON THE DISTAL EDGE OF THE TAB AND THE UNDERSIDE OF THE ARCH OF THE INSERTION HANDLE. THIS IS CONSISTENT WITH IMPACT IN THE DIRECTION OF DISASSEMBLY. THE RETURNED DEVICES WERE FUNCTIONALLY TESTED TOGETHER. AT NO TIME DID THE DEVICES FAIL TO ASSEMBLE/DISASSEMBLE AND NO BINDING WAS OBSERVED. THUS, THE COMPLAINT CONDITION FOR THE INSERTION HANDLE IS UNCONFIRMED AND COULD NOT BE REPLICATED. THE INSERTION HANDLE WAS DETERMINED TO FUNCTION AS INTENDED AND TO HAVE NOT CONTRIBUTED TO THE COMPLAINT CONDITION. THUS, NO FURTHER INVESTIGATION ON THIS DEVICE IS WARRANTED. THE DISTAL THREADS AND THE DISTAL SHAFT OF THE CONNECTING SCREW SHOW WEAR AND SCRAPING. THIS IS INDICATIVE OF THE PART BEING CROSS THREADED AND SCRAPING AGAINST THE MATING NAIL. HOWEVER, THE ASSOCIATED NAIL WAS NOT RETURNED, THEREFORE FURTHER TESTING WITH THE NAIL IN QUESTION WAS UNABLE TO BE PERFORMED. WHEN TESTED WITH A FUNCTIONAL NAIL (PART 04.034.555S / LOT H161903) THE CONNECTING SCREW COULD BE FULLY CONNECTED BUT WAS DIFFICULT TO ADVANCE/RETRACT ONCE THE NON-THREADED PORTION OF THE CONNECTING SCREW REACHED THE EDGE OF THE NAIL. THUS, THE COMPLAINT CONDITION FOR THIS DEVICE IS CONFIRMED, CONSISTENT WITH THE REPORTED CONDITION, AND COULD BE REPLICATED. A REVIEW OF THE CURRENT DRAWING / MANUFACTURED REVISION WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE DAMAGE ON THE THREADS AND SHAFT OF THE CONNECTING SCREW HAS RESULTED IN THE DIFFICULTY TO ASSEMBLE AND DISASSEMBLE A NAIL WITH THE INSERTION HANDLE AND CONNECTING SCREW. HOWEVER, THE DEFINITIVE ROOT CAUSE WHICH LED TO THIS OCCURRENCE COULD NOT BE DETERMINED GIVEN THE UNKNOWN CIRCUMSTANCES DURING AND PRIOR TO 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.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT PROVIDED 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 REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: 03.010.440, LOT 14-6678, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 29 AUGUST 2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE 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.

    Description of Event or Problem · 1

    IT IS REPORTED PATIENT WAS IMPLANTED WITH A 9MM TIBIAL NAIL, LEFT, USING THE SUPRAPATELLAR METHOD. AT THE COMPLETION OF THE IMPLANT PROCEDURE, SURGEON HAD DIFFICULTY REMOVING THE CONNECTING SCREW FROM THE INSERTION HANDLE. THE USE OF A WRENCH AND EXCESSIVE FORCE WERE REQUIRED TO REMOVE THE CONNECTING SCREW, THUS ALLOWING THE SURGEON TO THEN REMOVE THE INSERTION HANDLE FROM THE NAIL. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO FURTHER HARM TO PATIENT. ISSUE DID CREATE A 5 MINUTE DELAY IN THE PROCEDURE. INSERTION HANDLE AND CONNECTING SCREW WERE CHECKED AFTER THE PROCEDURE, BUT NO DEFECTS COULD BE DETECTED. THIS COMPLAINT IS FOR 2 DEVICES. CONCOMITANT DEVICES REPORTED: 9MM CANNULATED TIBIAL NAIL-EX (PART NUMBER 04.034.349S, LOT NUMBER 9917816, QUANTITY 1). THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642314 INSERTION HANDLE FOR SUPRAPATELLAR NAIL,FIXATION,BONE JDS SYNTHES SELZACH 14-6678

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR 04.034.349S, 9MM CANNULATED TIBIAL NAIL-EX