Catalog Number 94624 |
Device Problem
Fracture (1260)
|
Patient Problems
Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/15/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
|
|
Event Description
|
It was reported that during the procedure the tip of the torque wrench broke inside the locking nut when the doctor was trying to remove the cross connector.There was no further surgical information provided and no reported patient impacts.
|
|
Event Description
|
It was reported that during the procedure the tip of the torque wrench broke inside the locking nut when the doctor was trying to remove the cross connector.There was no further surgical information provided and no reported patient impacts.New information was received that reported the tip was retrieved and the cross connector was removed.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The event was confirmed with product received.Upon visual inspection the tip was deformed/twisted.The dhr was unable to be located.A corrective action has previously been initiated to address the issue.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|