Model Number N/A |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/13/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported during a hip arthroplasty the thread on the end of the impactor broke during impaction.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Product was not returned.Visual examination of provided pictures identified the thread of the impactor has fractured off.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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
|