MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA NEXTAR SHOULDER PIN Ø3,2 L=100 HA3,5-MECHE-TRIANGLE; NEXTAR SHOULDER TARGET HOLDER PIN

Model Number	02.07.10.2299
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The coracoidal process fractured during implant reduction.Placing the target pins into this bone may have weakened it.The surgeon cabled the fracture and the surgery was completed successfully.
Additional Manufacturer Narrative
The nextar shoulder rsa surgical techniques have been updated to include the following warning: target fixation requires adequate coracoid bone stability.Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture.Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.This change is going to be notified to final users following the recall procedure.
Additional Manufacturer Narrative
On 29 february 2024, during a check, we have found two errors in the initial mdr report (mdr 2022-00596): labeled for single use? - it is written "yes" but it has to be "no".Usage of device - it is written "initial use" but it has to be "reuse".

• Brand Name: NEXTAR SHOULDER PIN Ø3,2 L=100 HA3,5-MECHE-TRIANGLE
• Common Device Name: NEXTAR SHOULDER TARGET HOLDER PIN
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15208233
• Report Number: 3005180920-2022-00596
• Device Sequence Number: 13970220
• Product Code: LXH
• UDI-Device Identifier: 07630040763233
• UDI-Public: 07630040763233
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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: 02.07.10.2299
• Device Catalogue Number: 02.07.10.2299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 07/13/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/27/2022; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FSN 2022-03
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White