Catalog Number 160177 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/03/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
|
|
Event Description
|
The blue piece from the impactor broke into two pieces while implanting tibial plate.The broken parts were removed from the field.There were not any adverse consequences to the patient or user.Case type: pka.
|
|
Manufacturer Narrative
|
An event regarding crack/fracture involving a mako impactor was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: no medical records were received for review with a clinical consultant.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as product return and images of the device taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
The blue piece from the impactor broke into two pieces while implanting tibial plate.The broken parts were removed from the field.There were not any adverse consequences to the patient or user.Case type: pka.
|
|
Search Alerts/Recalls
|