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

Model Number N/A

Device Problems Fracture (1260); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

It was reported during a rotator cuff repair with a quattro x3 peek anchor, the anchor did not advance.During the procedure, a pilot hole was created, the anchor was inserted into the pilot hole and was being turned to implant but did not advance after a few turns.It was noted the surgeon backed out the anchor out of the pilot hole where it was observed to have a split in the peek on the tip of the anchor.Anchor was removed from the joint and it was clear no piece of the anchor had broken off.Surgery was completed with a second device and implanted without issue.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Part# cm-9255x3, quattro x3 anchor 5.5mm, lot# 75559-1.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.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.

Event Description

No further event information available at the time of this report.

• Brand Name: QUATTRO X3 ANCHOR 5.5MM
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• MDR Report Key: 12408408
• MDR Text Key: 280775306
• Report Number: 3006108336-2021-00037
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00887868270284
• UDI-Public: (01)00887868270284(17)250821(10)77235-1
• Combination Product (y/n): N
• PMA/PMN Number: K112814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM-9255X3
• Device Lot Number: 77235-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 61 YR