MAUDE Adverse Event Report: CAYENNE MEDICAL SURELOCK 1.4MM FLEX ANCHOR

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

Customer indicated that device is not available for evaluation.Complaint was not confirmed, and the root cause of this event cannot be determined.Dhr was reviewed, and no related anomalies were noted.Dfmea was investigated for the failure mode, and it is captured.Cayenne will continue to monitor for future events.

Event Description

It was reported that surelock anchor malfunctioned during surgery.Another device was used to complete the surgery leading to more drilled holes in the patient than intended.No other patient harm or significant surgical delay was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as an additional cut to the bone is considered to not be a serious injury.The initial report should be voided.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 Description

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

• Brand Name: SURELOCK 1.4MM FLEX ANCHOR
• Type of Device: SURELOCK
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• MDR Report Key: 10508793
• MDR Text Key: 206190976
• Report Number: 3006108336-2020-00023
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00887868270482
• UDI-Public: 00887868270482
• Combination Product (y/n): N
• PMA/PMN Number: K132867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-9614F
• Device Lot Number: 75153-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR