BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECSCR F/DFN F/357.120

    MDR report key: 5487159 · Received March 8, 2016

    Report

    Report Number
    2520274-2016-11540
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    February 23, 2016
    Report Date
    February 23, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A MANUFACTURING EVALUATION WAS COMPLETED: RECEIVED ONE CONNECTING SCREW PART 357.132. THE ARTICLE IS IN A USED CONDITION, HEAVY HAMMER STROKES ARE PRESENT AT THE HEAD OF THE CONNECTING SCREW. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT. DURING MANUFACTURING INVESTIGATION, ALL RELEVANT CHARACTERISTICS WERE CHECKED. IT HAS BEEN OBSERVED THAT A THREAD IS PARTLY DAMAGED. THE GO SIDE OF THE THREAD RING GAGE IS ONLY PASSING THE FIRST 5 - 6 TURNS, BUT NOT PASSING THE ENTIRE LENGTH OF 16 MM. IT IS LIKELY THAT THE DAMAGE WAS CAUSED BY HEAVY HAMMER STROKES ON THE HEAD OF THE CONNECTING SCREW WHEN THE THREAD WAS IN MESH WITH THE SPIRAL BLADE IMPLANT. IN OUR OPINION IS THE DAMAGE OF THE THREAD NOT IN RELATION TO THE REPORTED ISSUE. ALL OTHER CHECKED CHARACTERISTICS ARE WITHIN THE SPECIFICATIONS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN CONNECSCR F/DFN F/357.120, UNKNOWN LOT NUMBER. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE IS AN INSTRUMENT OR IMPLANT. WILL UPDATE WHEN DEVICE IS RECEIVED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 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 THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 05 AUGUST 2003, 357.132, LOT. 1188037. DHR NOT AVAILABLE AS DEVICE IS OLDER THAN 12 YEARS. AT THIS TIME THE MANUFACTURING DOCUMENTS FOR INSTRUMENTS HAD TO BE STORED FOR 10 YEARS. THIS WAS ACCORDING TO SE_075477 (FILING AND ARCHIVING OF SPECIFICATION DOCUMENTS) VERSION AI, WHICH WAS IN PLACE TILL AUGUST 2014. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SURGERY FOR SUPRACONDYLAR FEMUR FRACTURE APPLYING DFN TOOK PLACE ON (B)(6) 2016. AFTER THE SURGEON COMPLETED THE SPIRAL BLADE INSERTION, HE FOUND THAT THE DISTAL SPIRAL BLADE WAS OUT OF BOUNDS. HE EVENTUALLY REMOVED THE SPIRAL BLADE, CONNECTED TO THE INSERTION HANDLE IN QUESTION, AND REINSERTED AFTER HE MEASURED THE LENGTH AGAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A 30-MINUTES SURGICAL DELAY. NO ADVERSE CONSEQUENCE WAS REPORTED. THIS COMPLAINT INVOLVES THREE PARTS THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142626 CONNECSCR F/DFN F/357.120 MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 1188037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention