MAUDE Adverse Event Report: CAYENNE MEDICAL BIOWICK SURELOCK ANCHOR 2.7MM; BIOWIXK

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation because device remains implanted.Dhr was reviewed and no discrepancies were found.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.Remains implanted.

Event Description

It was reported that patient suffered from increased pain in the right shoulder and neck, radiating to fingers post surgery.Surgeon classified the pain as moderate and not related to the biowick device.Patient was treated with medication.

• Brand Name: BIOWICK SURELOCK ANCHOR 2.7MM
• Type of Device: BIOWIXK
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• Manufacturer Contact: shima hashemian ; 16597 n 92nd street; 101; scottsdale, AZ 85260 ; 4805023661
• MDR Report Key: 10376660
• MDR Text Key: 201999776
• Report Number: 3006108336-2020-00022
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM-6127
• Device Lot Number: 68568-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 73