MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO X3 ANCHOR 5.5MM; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during rotator cuff surgery, surgeon made a pilot hole for medial row anchor and when the implant was opened, it was found to be bent and was not used.Another device was used to complete the surgery.Upon evaluation of the returned product, the anchor was found to be fractured.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Report source: foreign country: (b)(6).Visual examination of the returned product identified the product was returned with minimal signs of use.The anchor is in place on the tip of the inserter but the tip of the anchor is fractured.The sutures are holding it in place and the sutures are neatly tucked into the handle.No other damage present and no packaging was retuned with the device medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

• Brand Name: QUATTRO X3 ANCHOR 5.5MM
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• MDR Report Key: 12463284
• Report Number: 3006108336-2021-00038
• Device Sequence Number: 14355728
• Product Code: MBI
• UDI-Device Identifier: 00887868270284
• UDI-Public: (01)00887868270284(17)250410(10)75802-1
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 04/10/2025
• Device Model Number: N/A
• Device Catalogue Number: CM-9255X3
• Device Lot Number: 75802-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/13/2021
• 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