Catalog Number 046W1AN00640 |
Device Problem
Fracture (1260)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 04/14/2022 |
Event Type
Injury
|
Event Description
|
It was reported that the tips of three instinct java screwdrivers broke on three different closure tops during final tightening intra-operatively.One of the broken tips of the screwdriver could not be removed from the closure top and remains implanted.The surgery was completed with another device.This is report two of three for this event.
|
|
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 3003853072-2022-00003 through 3003853072-2022-00005.
|
|
Event Description
|
It was reported that the tips of three instinct java screwdrivers broke on three different closure tops during final tightening intra-operatively.One of the broken tips of the screwdriver could not be removed from the closure top and remains implanted.The surgery was completed with another device.This is report two of three for this event.
|
|
Manufacturer Narrative
|
Device evaluation: visual inspection revealed that the tips of each devices were twisted and fractured.One fractured off tip was returned.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to applying off-axis forces to the driver.Dhr review : per dhr review, the parts were likely conforming when they left zimvie control.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
|
|
Search Alerts/Recalls
|