Catalog Number 89-8521-470-40 |
Device Problems
Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/09/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Zimmer biomet complaint (b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.
|
|
Event Description
|
It was reported that the aseptic battery housing, part number 89-8521-470-40, lot number 5014069 was opening up and exposing aseptic battery during a live case.This event is related to a malfunction that could potentially lead to a serious injury or sterility issue.As a result, a delay of 5 minutes was reported.There was no harm or injury to patient/operator reported.This event was reported for 6 aseptic battery housings, part number 89-8521-470-40, lot number 5014069, therefore 6 reports will be submitted.
|
|
Event Description
|
It was reported that the aseptic battery housing, part number 89-8521-470-40, lot number 5014069 was opening up and exposing aseptic battery during a live case.This event is related to a malfunction that could potentially lead to a serious injury or sterility issue.As a result, a delay of 5-10 minutes was reported.There was no harm or injury to patient/operator reported.This event was reported for 6 aseptic battery housings, part number 89-8521-470-40, lot number 5014069, therefore 6 reports will be submitted.
|
|
Manufacturer Narrative
|
Zimmer biomet complaint: (b)(4).This follow-up report is being submitted to relay device evaluation and corrected information in b5.Corrected information regarding section b5: the reported delay in surgery was 5-10 mins.Device evaluation: aseptic battery housing, part number 89-8521-470-40, lot number 5014069, was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the device had a locking system issue with the lid while applying excessive force.The device was not repairable and it was recycled in zimmer biomet premises.The event reported by the customer was confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A summary of the investigation was sent to the complainant.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
|
|