Model Number 399.78 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that while processing in decontamination on november 24, 2021, the speed lock reduction forceps was found to be broken.There was no patient involvement.This report is for a reduction forceps with points speed lock 205mm.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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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It was reported that while processing in decontamination on (b)(6) 2021, the speed lock reduction forceps was found to be broken.There was no patient involvement.This report is for a reduction forceps with points speed lock 205mm.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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