HIP KIT

Description of Event or Problem

It was reported that during surgery, the unit malfunctioned. It was not spraying water from the device. Battery expulsion was confirmed after final assessment. There was no patient impact or delay. Due diligence is complete as no further information is available.

Additional Manufacturer Narrative

This complaint is recorded by Zimmer Biomet under (b)(4).Visual examination of the returned product/provided pictures identified that the device was returned with the batteries removed from the pack. Functional testing found the device did power on and function normally in both modes when connected to a lab battery pack. Visual inspection of the interior of the pack found electrolyte leaked inside of the pack. There did not appear to be damage to the wiring of the pack. No other damage was found.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause is attributed to a manufacturing issue exacerbated by a design issueThe event is confirmedIf 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.G2: Foreign - Event occurred in China.