MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 46MM LGTH; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW, 5.0 LG, 46MM LGTH
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.Upon functional testing, it was found that the 5.0 mm metal compression screw does not mate with corresponding hexalobe t15 driver.Upon visual evaluation, no problem found with the device.The cause remains process related.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8750-46h large compression ft screw did not fit into any t15 hex drivers.A new ar-8750-46h large compression ft screw was opened to complete the case successfully without further issues.This was discovered during a calcaneus osteotomy procedure on (b)(6) 2023.

• Brand Name: COMPR FT SCRW, 5.0 LG, 46MM LGTH
• 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: 19382063
• Report Number: 1220246-2024-03733
• Device Sequence Number: 14399259
• Product Code: HRS
• UDI-Device Identifier: 00888867262942
• UDI-Public: 00888867262942
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: COMPR FT SCRW, 5.0 LG, 46MM LGTH
• Device Catalogue Number: AR-8750-46H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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