This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated: b4, d4, d10, g4, g7, h2, h3, h4, h6, h10.D4 - udi no.: (b)(4).The device history record (dhr) for 00515047501 lot number 64245126, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) hospital that this product didn't work at all from the start of use.On 13 january 2020, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the batteries had ruptured inside of the battery pack of the device, and there was evidence of rust and corrosion throughout.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515047501 was not working due to ruptured batteries inside of the battery pack, it cannot be determined from the information provided what actually caused the batteries to rupture.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.
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