Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 08/22/2019 |
Event Type
Injury
|
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 that during surgery, the drill bit fractured inside the patient.The fractured piece remains inside the patient.Attempts have been made and additional information on the reported event is unavailable.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h4; h6.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
|
|
Search Alerts/Recalls
|