Model Number N/A |
Device Problem
Misfire (2532)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/22/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Reference: (b)(4).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 two crossfix devices misfired during a surgery.Surgeon decided to leave the meniscus as-is with no repair.No other patient harm or surgical delay was reported.
|
|
Event Description
|
It was reported that two crossfix devices misfired during a surgery.Surgeon decided to leave the meniscus as-is with no repair.No other patient harm or surgical delay was reported.
|
|
Manufacturer Narrative
|
Reference: (b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The root cause of this event is determined to be a possible use error, where the user torqued the dual needles during use.Dhr was reviewed and no discrepancies were found.A summary of the investigation will be sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|