MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE LOCKING SCREW, 3.5 X 30 MM; SCREW, FIXATION, BONE

Model Number	LOW PROFILE LOCKING SCREW, 3.5 X 30 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw broke inside the patient.The device remained inside the patient.No further information was provided.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
Update avoe 10-jan-2024.It was confirmed that the initial surgery took place on the (b)(6) 2023.The minimal invasive plate osteosynthesis (mipo) was completed successfully.Due to the device breakage a second surgery was required on the (b)(6) 2023.
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 description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: LOW PROFILE LOCKING SCREW, 3.5 X 30 MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18464537
• Report Number: 1220246-2024-00184
• Device Sequence Number: 12529157
• Product Code: HWC
• UDI-Device Identifier: 00888867179608
• UDI-Public: 00888867179608
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: LOW PROFILE LOCKING SCREW, 3.5 X 30 MM
• Device Catalogue Number: AR-8835L-30S
• Device Lot Number: 13641136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 03/11/2025
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/05/2024; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown