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	11/06/2024
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 univers revers shoulder surgery when screwing in the screw, the head of the screw broke off.The base plate was nevertheless fixed.The screw head was disposed of and the remaining screw remained in the patient.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: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, specifically, excessive force, misalignment of the insertion or improper bone preparation.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• 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: 21035557
• Report Number: 1220246-2024-09108
• Device Sequence Number: 8539277
• Product Code: KWS
• UDI-Device Identifier: 00888867135765
• UDI-Public: (01)00888867135765(11)200421(17)250331(10)10859273
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/01/2025

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 Expiration Date: 03/31/2025
• Device Model Number: PERIPHERAL SCREW, NL, UNI REV, 4.5X30MM
• Device Catalogue Number: AR-9145-30NL
• Device Lot Number: 10859273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2020
• 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
• Patient Sex: Unknown