This event has been recorded under zimmer biomet complaint number: (b)(4).The following sections have been corrected/updated: b4 (date of report), d4 (serial#) , g4 (pma/510k), h1 (type of reportable event), h2 (if follow-up, what type), h3 (device evaluated by mfr), h4 (device manufacture date), h6, h10.The device history record for zimmer skin graft mesher serial number: (b)(6) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 28 june 2019, it was reported that the ratchet for a mesher was not working.The customer was asked to return zimmer skin graft mesher serial number: (b)(6) for evaluation, however, at the time of the investigation, the device has yet to be returned.As such, no evaluation or repair of the device can be reviewed as part of the investigation.The device was not returned for evaluation or repair.As such, 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 that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.H3 other text : product was not returned.
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