MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 4.5MM; PROSTHESIS, SPORTS MEDICINE

Catalog Number CM-9145

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the returned product identified obvious signs of use.The anchor is fractured near the tip and all pieces appear to be present.The anchor is still attached to the inserter and could be removed from the inserter.One of the prongs of the inserter is bent and makes removing the anchor difficult but possible.The handle has no obvious signs of damage and the knob and switch are functional.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

Event Description

It was reported that approximately three (3) weeks ago during a rotator cuff repair, the tip of the anchor broke while the surgeon was advancing the awl.Patient did not experience any harm as a result of the anchor fracturing.Attempts have been made and no further information has been provided.

• Brand Name: QUATTRO LINK ANCHOR 4.5MM
• Type of Device: PROSTHESIS, SPORTS MEDICINE
• 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: 11251565
• MDR Text Key: 244387641
• Report Number: 3006108336-2021-00007
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00887868270192
• UDI-Public: (01)00887868270192
• 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,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CM-9145
• Device Lot Number: 77516-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 74