MAUDE Adverse Event Report: ARTHREX, INC. PERIPHERAL SCREW, NL, UNI REV, 4.5X30MM; PROSTHESIS, SHOULDER, CEMENTED

Model Number	PERIPHERAL SCREW, NL, UNI REV, 4.5X30MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a shoulder arthroplasty case with arthrex eclipse + universal glenoid when screwing in the peripheral screw 30 mm it broke off.The screw was inserted using the torque indicating adaptor.The head of the screw broke off; the threaded part of the screw remained in the baseplate/bone.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the peripheral screw, non-locking, univers revers¿ 4.5 x 30 mm, identified that the screw was broken off.The head was returned with abrasion marks around it.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user-applied excessive force during the tightening process and/or prying/leveraging of the device during insertion.

• Brand Name: PERIPHERAL SCREW, NL, UNI REV, 4.5X30MM
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23064687
• Report Number: 1220246-2025-03886
• Device Sequence Number: 18562064
• Product Code: KWS
• UDI-Device Identifier: 00888867135765
• UDI-Public: (01)00888867135765(11)220817(17)270731(10)14992607
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K130129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PERIPHERAL SCREW, NL, UNI REV, 4.5X30MM
• Device Catalogue Number: AR-9145-30NL
• Device Lot Number: 14992607
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown