MAUDE Adverse Event Report: SHOULDER INNOVATIONS, INC. SHOULDER INNOVATIONS INSET REVERSE TOTAL SHOULDER - RSA 24MM ANGLED REAMER (0°); GLENOID REAMER

Model Number	RSA 24mm Angled Reamer (0 deg)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Glenoid fracture during use of 24mm x 0° angled reamer.
Additional Manufacturer Narrative
Fracture occurred intraoperatively during reaming and was addressed by surgeon immediately using bone screw fixation for support/stabilization.The reverse shoulder implantation then proceeded with no further issues.

• Brand Name: SHOULDER INNOVATIONS INSET REVERSE TOTAL SHOULDER - RSA 24MM ANGLED REAMER (0°)
• Common Device Name: GLENOID REAMER
• Manufacturer (Section D): SHOULDER INNOVATIONS, INC.; 1535 steele ave sw; suite b; grand rapids MI 49507
• Manufacturer Contact: len tokish ; 1535 steele ave sw; suite b; grand rapids, MI 49507 ; 2016947331
• MDR Report Key: 16165173
• Report Number: 3012544635-2023-00001
• Device Sequence Number: 2331112
• Product Code: HTO
• UDI-Device Identifier: B1132R2GR400240
• UDI-Public: B1132R2GR400240
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K210533
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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: RSA 24mm Angled Reamer (0 deg)
• Device Catalogue Number: 2R2GR40024
• Device Lot Number: SGIA01-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown