Catalog Number 03.010.411 |
Device Problem
Break (1069)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
Additional procode: hxx.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.
|
|
Event Description
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the surgeon wanted to remove a pfna from a patient at the patient's request.When the surgeon attempted to extract the blade, the threaded part of the blade extraction screw broke.The surgeon managed to remove the fragment and the ablation operation could not continue.The pfna removal was not possible without this instrument.The procedure was postponed to (b)(6) 2020.There is no further information available.Concomitant devices reported: unknown pfna nail (part# unknown, lot# unknown, quantity# 1) unknown pfna blade (part# unknown, lot# unknown, quantity# 1).This report is for one (1) extraction screw for pfna blade.This is report 1 of 1 for (b)(4).
|
|
Search Alerts/Recalls
|
|