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Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for an unknown plates: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent the removal surgery of the tomofix plate for the proximal tibia.During the surgery, the surgeon could not remove the screws with the screwdriver.The surgeon replaced the handle with a t-handle which belonged to the hospital and tried to remove the screws, but the head of the screws stripped.The surgeon used the extraction screw; however, the tip of the extraction screw broke.The surgeon was able to remove the screws by chipping the head of the screws with the carbide drill and cut off from the plate.The surgery was completed successfully within 30 minutes delay.No fragments remain in the patient.The patient was reported as stable.This report involves one (1) unknown plates: trauma.This is report 4 of 4 for (b)(4).
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Search Alerts/Recalls
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