MAUDE Adverse Event Report: BRM EXTREMITIES S.R.L. BRM DIGITALIS SPACER; PROSTHESIS, FINGER, CONSTRAINED POLYMER

Model Number	DIGITALIS MCP SPACER SIZE 4
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted device was returned to the manufacturer and analyzed.No defect was visible on the device.
Event or Problem Description
The patient is a 73-year-old male who previously had an extensor tendon realignment and subsequently has worsening of his arthritis.He was submitted to mp joint silicone arthroplasties and extensor tendon realignment to 4 fingers of the left hand (index, long, ring and small finger.The surgical intervention happened on (b)(6) 2024.The operating procedure states that the extensor tendons to the long, ring and small finger, edc and edm were densely stuck in scar tissue from prior surgery, so the surgeon had to perform an extensive tenolysis on all four tendons.The implants were then implanted.A week after surgery, the patient states that all the implants are dislocated.The patient claims using a rigid spint since surgery.After the analysis of the relevant documentation and x-rays and consultation with a clinical expert, the manufacturer identified soft tissue instability as the reason for the dislocation.This is report 3 of 4.

• Brand Name: BRM DIGITALIS SPACER
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED POLYMER
• Manufacturer (Section D): BRM EXTREMITIES S.R.L.; via mascheroni 29; milano, mi 20145 ; IT 20145
• Manufacturer (Section G): BRM EXTREMITIES; via privata ai campi 7; civate, lc 23862 ; IT 23862
• Manufacturer Contact: lisa fazzini ; via privata ai campi, 7; civate, lc IT-23-862 ; IT IT-23862
• MDR Report Key: 20395086
• Report Number: 3016669046-2024-00003
• Device Sequence Number: 15116463
• Product Code: KYJ
• UDI-Device Identifier: 08057717554540
• UDI-Public: (01)08057717554540(10)1223/23(17)280731
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K220142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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: DIGITALIS MCP SPACER SIZE 4
• Device Catalogue Number: DDG3T01004
• Device Lot Number: 1223/23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male