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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 12/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: 510k: this report is for an unknown plate/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), 2021, the patient underwent an open reduction internal fixation surgery.When the surgeon tried to insert the locking screw to the most distal hole of a plate, torque did not apply, and the locking screw did not lock.The surgeon did not insert the locking screw but inserted another screw into the other hole.The surgery was completed with no surgical delay.No further information is available.This report is for one (1) unknown plate.This is report 2 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Additional narrative: 510k: this report is for an unknown plate/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) 2021, the patient underwent an open reduction internal fixation surgery.When the surgeon tried to insert the locking screw to the most distal hole of a plate, torque did not apply, and the locking screw did not lock.The surgeon did not insert the locking screw but inserted another screw into the other hole.The surgery was completed with no surgical delay.No further information is available.This report is for one (1) unknown plate.This is report 2 of 2 for complaint (b)(4).
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Search Alerts/Recalls
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