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

Model Number MDS110302C

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 03/09/2021

Event Type  Injury  

Event 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
• Type of Device: CERCLAGE BUTTON, 3.5T
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS; 7620 nw 25 st suite 3 & 4; miami FL 33122
• Manufacturer (Section G): BIEDERMANN MOTECH; 7620 nw 25 st; miami FL 33122
• Manufacturer Contact: joselito hernnadez ; 7620 nw 25 st; miami, FL 33122 ; 3057225310
• MDR Report Key: 11544253
• MDR Text Key: 242385782
• Report Number: 3009222247-2021-00005
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10812269023150
• UDI-Public: (01)10812269023150(10)116464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDS110302C
• Device Catalogue Number: MDS110302C
• Device Lot Number: 116464
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR