MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 12MM, CORTICAL; BONE FIXATION PLATE

Model Number	LOW PROFILE SCREW, 1.6 X 12MM, CORTICAL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-18716-12 low profile screw, 1.6 x 12mm, cortical screw broke off in the patient's bone.The implant remains in the patient.This was discovered during an orif 3rd metacarpal fracture procedure on (b)(6) 2023.Additional information received on (b)(6) 2023: a small portion of the screw was retrieved; however, the head of the screw was lost in the soft tissue, and the tip of the screw remains in the patient.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 based on the x-ray submitted for evaluation from the field, it is evident that the screw head was detached.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.
Event or Problem Description
The screw was inserted entirely by hand, and the bone was drilled bi-cortically.

• Brand Name: LOW PROFILE SCREW, 1.6 X 12MM, CORTICAL
• Common Device Name: BONE FIXATION 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: emily shafer ; 8009337001
• MDR Report Key: 17246723
• Report Number: 1220246-2023-07017
• Device Sequence Number: 4871796
• Product Code: HRS
• UDI-Device Identifier: 00888867313248
• UDI-Public: 00888867313248
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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 Model Number: LOW PROFILE SCREW, 1.6 X 12MM, CORTICAL
• Device Catalogue Number: AR-18716-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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