Catalog Number 03.111.005 |
Device Problems
Device-Device Incompatibility (2919); Material Deformation (2976)
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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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Device report from synthes reports an event in (b)(6) as follows: it was reported that, both the drill guides have chips in them.The depth gauge was bent and did not hook.No patient consequences.This report is for one (1) depth gauge f/scr ø2-2.7 meas-range up-t.This is report 2 of 3 for complaint (b)(4).
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Manufacturer Narrative
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If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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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If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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, both the drill guides have chips in them.The depth gauge was bent and did not hook.No patient consequences.This report is for one (1) depth gauge f/scr ø2-2.7 meas-range up-t.This is report 2 of 3 for complaint (b)(4).
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Search Alerts/Recalls
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