|
Device Problem
Component Missing (2306)
|
Patient Problems
Injury (2348); No Code Available (3191)
|
Event Date 01/01/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Only event year is known.This report is for an unknown plates: tibia /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review /investigation.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.(b)(4).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 an unknown date, that during an unknown procedure that the surgeon did not have the correct implants.The surgeon received a 3.5 system for the proximal tibia, in which the longest plate was sixteen (16) holes.Prior to starting the procedure, the surgeon said it was fine to use the 3.5 system.The patient was anesthetized but the skin was not incised.The surgeon externally measured the plate and realized the 3.5 system could not be used.The surgeon stated that he requested the 30 cm plate, which was in the 4.5 system.The patient received a cast.This report involves one (1) unknown plates: tibia.This is report 1 of 1 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|