MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 20MMCORT, STRL; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW,TI,3.0MMX 20MMCORT, STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.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 surgery the screws inserted into patient but head of screw sheared off.It was further reported that shafts remained in patient.No further information received.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the device(s) were not returned for evaluation.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 a user error applying excessive force.The complaint allegation was confirmed based on the customer's attached picture showing a damaged device.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 20MMCORT, STRL
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 18807760
• Report Number: 1220246-2024-01209
• Device Sequence Number: 17977406
• Product Code: HWC
• UDI-Device Identifier: 00888867210547
• UDI-Public: 00888867210547
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 11/30/2024
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 20MMCORT, STRL
• Device Catalogue Number: AR-8933-20S
• Device Lot Number: 10505168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2019
• 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