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, d10, g4, g7, h2, h3, h4, h5, h6, h8, h10.The device history record (dhr) for the zimmer air dermatome ii hose: synthes (ao), 3 m, part number 00885100203 and serial number (b)(6), review by de-soutter medical limited 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) 2020, a returned product investigation was performed on the zimmer air dermatome ii hose: synthes (ao), 3 m.The physical evaluation revealed that the o-ring that seals the airflow from the hose was mis-seated which allowed for air to leak from the hose.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the zimmer air dermatome ii hose: synthes (ao), 3 m had a mis-seated o-ring causing an air leak, it cannot be determined from the information provided what actually caused the reported event.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.
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