MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,14MM LGTH, STRL; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,2.5 MICRO,14MM LGTH, STRL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.A guide wire may have been placed inside the box by a facility employee, an arthrex representative or during the manufacturing process, however, due to the device not being returned, we cannot confirm the source of how the guide wire was introduced.
Event or Problem Description
On 1/06/2023, it was reported by a arthrex representative via email that an ar-8725-14hs compression ft screw has a guide wire inside the screw.The case was completed using a new product.This was discovered upon opening box on (b)(6) 2022, with no patient effect reported.Additional information received on 1/09/2023: staff noticed the issue before the surgery.The case was completed using an ar-8725-14hs compression ft screw.No photos were taken.Additional information received on 1/12/2023: this was discovered during a procedure to fix the fingers of the hand.

• Brand Name: COMPR FT SCRW,2.5 MICRO,14MM LGTH, 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: 19564001
• Report Number: 1220246-2024-06040
• Device Sequence Number: 20390502
• Product Code: HRS
• UDI-Device Identifier: 00888867278493
• UDI-Public: 00888867278493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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 Expiration Date: 12/31/2022
• Device Model Number: COMPR FT SCRW,2.5 MICRO,14MM LGTH, STRL
• Device Catalogue Number: AR-8725-14HS
• Device Lot Number: 10183565
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2018
• 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