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Catalog Number 04.503.225.01C |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional product code: (b)(4).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 china as follows: it was reported that on (b)(6) 2021, during midface fracture surgery, while inserting the screw, the screw head cross threads peeled.The screw was removed from the patient and another device was used to complete the surgery.There were no adverse consequences to the patient.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1) this report is for one (1) ti matrixmidface screw self-drilling 5mm.This is report 1 of 1 for complaint (b)(4).
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Search Alerts/Recalls
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