MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFLIE SCREW, CORITCAL, 2.7 X 12 MM; BONE FIXATION PLATE

Model Number	LOW PROFLIE SCREW, CORITCAL, 2.7 X 12 MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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
On 06/17/2024 it was reported by an arthrex subsidiary employee via email that an ar-8827-12s low profile screw fell out and could not be implanted.This was discovered during an open reduction of a fibular fracture procedure on (b)(6) 2024.Additional information received on 6/26/2024: the ar-8827-12s low profile screw was implanted but it pulled out.After multiple attempts, the surgeon gave up and decided the fixation would be fine with the other screws that were already implanted.The case was not delayed and additional anesthesia was not needed.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Visual inspection of the low profile screw¿, 2.7 x 12 mm, cortical, sterile had no issues.Dimensional testing of the major diameter and overall length were between tolerances.Functional testing was performed, and the device worked as intended.The most likely cause of the reported failure can be attributed to user error of the device due to misaligned insertion, prying/leveraging and/or excessive force being used during insertion of the screw.

• Brand Name: LOW PROFLIE SCREW, CORITCAL, 2.7 X 12 MM
• 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: jared engle ; 8009337001
• MDR Report Key: 19702330
• Report Number: 1220246-2024-06665
• Device Sequence Number: 7674204
• Product Code: HRS
• UDI-Device Identifier: 00888867178809
• UDI-Public: 00888867178809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: LOW PROFLIE SCREW, CORITCAL, 2.7 X 12 MM
• Device Catalogue Number: AR-8827-12S
• Device Lot Number: 14960299
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown