MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 4.5MM SP

Model Number N/A

Device Problem Disconnection (1171)

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

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Device was not returned for evaluation.Dhr was reviewed and no discrepancies relevant 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.Device remains implanted.

Event Description

It was reported that during surgery, anchor failed to lock in the sutures.The anchor was left in the patient, and another anchor was used to complete the surgery.30-40 minutes surgical delay was reported.No other patient harm was reported.

• Brand Name: QUATTRO LINK ANCHOR 4.5MM SP
• Type of Device: ANCHOR
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• Manufacturer (Section G): LSO; 830 challanger st; brea CA 92821
• Manufacturer Contact: shima hashemian ; 16597 n 92nd street; 101; scottsdale, AZ 85260 ; 4805023661
• MDR Report Key: 8800465
• MDR Text Key: 151366700
• Report Number: 3006108336-2019-00037
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2022
• Device Model Number: N/A
• Device Catalogue Number: CM9145SP
• Device Lot Number: 63877-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR