MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 4.5MM; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during surgery, the anchor failed to detach from insertion device.A replacement was opened.No adverse event or patient harm reported.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Report source : foreign : (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If 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.

• Brand Name: QUATTRO LINK ANCHOR 4.5MM
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer Contact: shima hashemian ; 16597 n 92nd street; scottsdale, AZ 85260 ; 4805023661
• MDR Report Key: 13315891
• Report Number: 3006108336-2022-00003
• Device Sequence Number: 11943734
• Product Code: MBI
• UDI-Device Identifier: 00887868270192
• UDI-Public: (01)00887868270192(17)230315(10)66282-2
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-9145
• Device Lot Number: 66282-2
• 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: 01/19/2022
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown