BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5495259 · Received March 11, 2016

    Report

    Report Number
    2520274-2016-11608
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 25, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE PROVIDED PART FAMILY INFORMATION, THE DEVICE NAME IS EITHER: 4.0MM CANNULATED SCREW SHORT THREAD (VARIETY OF LENGTHS) FOR PART FAMILY 207.6XX, 4.0MM CANNULATED SCREW LONG THREAD (VARIETY OF LENGTHS) FOR PART FAMILY 207.7XX. BASED UPON THE PROVIDED PART FAMILY INFORMATION, THE LIKELY 510K NUMBER FOR THE DEVICE IS: K963192. PRODUCT INVESTIGATION SUMMARY: ONE (1) 4.0MM CANNULATED SCREW (PART 207.6XX OR 207.7XX) WAS RETURNED FOR INVESTIGATION. THE IMPLANT WAS BROKEN THROUGH THE THREADS WITH THE TIP OF THE SCREW MISSING. APPROXIMATELY 30MM OF THE IMPLANT WAS RETURNED. SINCE THE BALANCE OF THE DEVICE WAS NOT RETURNED, THE EXACT PART NUMBER IS UNABLE TO BE DETERMINED. IT IS UNKNOWN WHAT CAUSED THE COMPLAINT CONDITION, BUT IT IS POSSIBLE THAT THE SCREW WAS INSERTED INTO EXCESSIVELY HARD BONE, WHICH LIKELY CAUSED THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE RELEVANT DRAWINGS FOR THE DEVICE WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THE DATE OF AWARENESS FOR THIS EVENT WAS REPORTED AS (B)(6) 2016 IN ERROR ON THE INITIAL MEDWATCH. THE CORRECT DATE OF AWARENESS WAS (B)(6) 2016. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT SUCCESSFULLY IMPLANTED OR FULLY EXPLANTED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN UNK - SCREW CANNULATED/UNKNOWN LOT NUMBER, PARTIAL PART NUMBER REPORTED AS 207.6XX 4MM CANNULATED SCREW. NOT EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 DURING SURGERY FOR A MEDIAL MALLEOLUS FRACTURE ON (B)(6) 2016, THE SURGEON WAS TRYING TO IMPLANT A 4 MM CANNULATED SCREW. DURING INSERTION, THE THREADS OF THE SCREW STARTED TO UNRAVEL. THE SCREW THREADS SEPARATED FROM THE SCREW BODY AND LODGED IN THE PATIENT'S DISTAL TIBIA. THE SCREW BODY WAS REMOVED; BUT THE THREADS REMAINED IN THE PATIENT. ANOTHER 4 MM CANNULATED WAS USED TO COMPLETE THE FRACTURE FIXATION. THERE WAS AN APPROXIMATE 15 MINUTE DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151358 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention