Model Number 2107-2200 |
Device Problem
Device Damaged by Another Device (2915)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 09/02/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
An event regarding damage involving a trident driver shaft was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot details and return of the device are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Not returned.
|
|
Event Description
|
The customer reported that three drill bits are blunt.Update: per sale rep response: "the surgeon feel that the flexible drill driver breaking may be as a result of the drill bit being blunt.The fragment in patient allegedly come from the flexible drill driver.We did not know about this until after the case when the post op xray showed the fragments of metal in the hip." "there was no delays to surgery.Surgery continued and finished as normal.".
|
|
Manufacturer Narrative
|
Corrected data: h1 corrected to "malfunction", as "serious injury" was inadvertently selected in initial mdr.An event regarding damage involving a trident driver shaft was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot details and return of the device are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
The customer reported that three drill bits are blunt.Update: per sale rep response: "the surgeon feel that the flexible drill driver breaking may be as a result of the drill bit being blunt.The fragment in patient allegedly come from the flexible drill driver.We did not know about this until after the case when the post op xray showed the fragments of metal in the hip." "there was no delays to surgery.Surgery continued and finished as normal.".
|
|
Search Alerts/Recalls
|