|
Catalog Number UNK - NAILS: TFNA |
Device Problem
Break (1069)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 05/01/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is for an unknown nails: tfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 the usa as follows: it was reported that on an unknown date and on unknown procedure, tfna nail breaking proximally at lag screw junction.This is the 4th or 5th nail that has broken in 2022.Something is wrong.Concomitant devices reported: unk - nail head elem: tfna lag screw (part# unknown, lot# unknown, qty 1).This complaint involves (1) device unk - nails: tfna.This is report 1 of 1 for complaint (b)(4).
|
|
Search Alerts/Recalls
|
|
|