MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS CERCLAGE BUTTON, 3.5T

Model Number	MDS110302C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had irritation on his shoulder, and the subject revision surgery had less to do with hardware and more to do with soft tissue evaluation.During the soft tissue (nerve) evaluation the surgeon decided to remove two cerclage buttons (part#: mds110302c lot#: 116464) and cerclage wire (unknown manufacturer, unknown part number, unknown, lot number).The items were replaced with two screws and two locking caps.There were no reported delays to the procedure and no impact to the patient's outcome as a result of the revision surgery.Product will not be returned.

• Brand Name: CERCLAGE BUTTON, 3.5T
• Common Device Name: CERCLAGE BUTTON, 3.5T
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS; 7620 nw 25 st suite 3 & 4; miami FL 33122
• MDR Report Key: 11544253
• Report Number: 3009222247-2021-00005
• Device Sequence Number: 17165653
• Product Code: HRS
• UDI-Device Identifier: 10812269023150
• UDI-Public: (01)10812269023150(10)116464
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K172786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MDS110302C
• Device Catalogue Number: MDS110302C
• Device Lot Number: 116464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR