Catalog Number 314.291 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Event Description
|
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that preoperatively the doctor could feel that something was wrong with the clamp, the device fell apart.The operation took longer because of not having the clamp to help the reduction hold, it is unknown how much longer the surgery took.No patient harm this is report 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Additional narrative: a manufacturing evaluation was completed: the investigation has shown that handle is broken off as complained.The review of the production history revealed that this instrument was manufactured in 2003.Considering the age of this article (more than 10 years old) it is likely that the handle is worn out due to the repeated reprocessing cycles, which the reposition clamp was subjected to and we classify this damage as a normal wear and tear.Device history records are not available as device is older than 10 years.The documents for instruments have to be stored for 10 years.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.
|
|
Manufacturer Narrative
|
Additional narrative: no non-conformance reports were generated during production.Review of the device history records 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.
|
|
Search Alerts/Recalls
|