Model Number 03.501.080 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Returned to manufacturer.Dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 05.Dec.2013.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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
|
It was reported that an application instrument for stenal zipfix was discovered to not tighten during an unknown procedure.No additional information is available.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
Concomitant device reported.Therapy date is unknown.No service history review can be performed as part number 03.501.080 with lot number(s) 8735246 is a lot/batch controlled item.The service history review is unconfirmed.Service and repair evaluation was completed.The customer reported the device would not tighten.The repair technician reported the trigger was sticking.Lube/oil/clean is the reason for repair.The cause of the issue is unknown.No parts were replaced.The item was repaired per the inspection sheet, passed synthes final inspection on 6-oct-2017 and will be returned to the customer upon completion of the service and repair process.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
|
Concomitant devices reported: stenal zipfix (part # unknown, lot # unknown, quantity: unknown).
|
|
Search Alerts/Recalls
|