MAUDE Adverse Event Report: CAYENNE MEDICAL VENTIX LINK KNTLS 5.5MM MACH; ANCHOR

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was not confirmed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that patient underwent revision surgery due to anchor migration.It was also reported by the hcp that there was nothing wrong with the device.No other patient harm was reported.

• Brand Name: VENTIX LINK KNTLS 5.5MM MACH
• Common Device Name: ANCHOR
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• MDR Report Key: 10026552
• Report Number: 3006108336-2020-00012
• Device Sequence Number: 16792514
• Product Code: MBI
• UDI-Device Identifier: 00887868269387
• UDI-Public: 00887868269387
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: N/A
• Device Catalogue Number: 110025992
• Device Lot Number: 70884-6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention