Catalog Number 046W0AN00002 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/23/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3003853072-2019-00166 to 3003853072-2019-00175.
|
|
Event Description
|
It was reported that during the procedure the threads of eight plugs were damaged, the torque handle was out of specification, and the tip of the driver fractured.The tip was removed and the case was completed using an alternate driver and closure tops.There were no patient impacts reported.This is report one of ten for this event.
|
|
Manufacturer Narrative
|
The devices were returned and the part and lot information on the parts matched the information in the complaint file.Visual inspection found that all 8 closure tops had outer thread damage.Additionally, one of the closure tops had hex damage as well.The complaint is confirmed for 8 closure tops having outer thread damage and 1 closure top having hex damage.The device history record (dhr) was reviewed.There were no nonconformances or temporary deviations associated with this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.It was reported that during the procedure the threads of eight plugs were damaged, the torque handle was out of specification, and the tip of the driver fractured.The tip was removed and the case was completed using an alternate driver and closure tops.The reported complaint of the damage plug was confirmed.The exact cause of this event could not be determine with the available information.However, the drive mechanism damage is consistent with improper seating of the driver in the drive mechanism during torquing or axial forces applied during torquing.The thread damage is consistent with improper seating of the closure top in the screw head during torquing, resulting in cross-threading and thread damage.
|
|
Event Description
|
It was reported that during the procedure the threads of eight plugs were damaged, the torque handle was out of specification, and the tip of the driver fractured.The tip was removed and the case was completed using an alternate driver and closure tops.There were no patient impacts reported.This is report one of ten for this event.
|
|
Search Alerts/Recalls
|