Catalog Number 254500060 |
Device Problem
Metal Shedding Debris (1804)
|
Patient Problem
No Information (3190)
|
Event Date 08/22/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Inspection by orthokit technicians revealed that it is difficult to remove the pin with the gripper.Fragments of the pin materials are removed when attempting to remove the pin with the gripper.These fragments could fall inside a patient.The affected product is new and has never been used.The issue was detected during set inspection, no patient harm or surgical delay is reported.
|
|
Manufacturer Narrative
|
Examination and functional testing of the returned device was unable to confirm the reported event.The returned attune pin puller was forwarded to the supplier for evaluation.There was no evidence of debris or issue associated with product during or after function testing.No product contribution to the reported event was identified.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|