MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS BROAD PLATE, 3.5T; BROAD PLATE, 3.5T, 14 HOLES

Model Number	MDS1101B14
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The subject plate was implanted, in a peri-prosthetic humeral repair, at or around (b)(6) 2020.The peri-prosthetic repair was to implant a mds1101b14 plate over a fracture caused by a fall at the distal end of the prosthetic stem.The patient was "doing fine" as reported by the revision surgery surgeon.At or around three (3) weeks prior to the subject revision surgery the patient fell in the shower without any indications of trauma to the bone or plate, as reported by the patient.A week prior to the subject revision surgery the patient woke up with pain and unable to move her arm.The subject revision surgery was to remove the broken plate.

• Brand Name: BROAD PLATE, 3.5T
• Common Device Name: BROAD PLATE, 3.5T, 14 HOLES
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS; 7620 nw 25 st suite 3 & 4; miami FL 33122
• MDR Report Key: 11250854
• Report Number: 3009222247-2021-00001
• Device Sequence Number: 11658546
• Product Code: HRS
• UDI-Device Identifier: 10812269024362
• UDI-Public: (01)10812269024362(10)18003563
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/28/2021

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: MDS1101B14
• Device Catalogue Number: MDS1101B14
• Device Lot Number: 18003563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention