MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPRESSION SCREW 3 X 18MM; BONE FIXATION SCREW/PLATE

Model Number	BIO-COMPRESSION SCREW 3 X 18MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
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 07/08/2025, a sales representative reported via email that an ar-5025b-18 bio-compression screw came out of the package with a crack in it.Upon attempting insertion, the screw broke further and was immediately removed from the patient.The surgery was completed using another ar-5025b-18 bio-compression screw from the same lot.The case was delayed minimally, and the patient was not harmed.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 07/15/2025: this issue was discovered during a cartilage repair procedure on (b)(6)2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.According to the event description, the device was used despite the crack being identified prior to use.Based on this information and the attached image, the complaint allegation remains classified as user error, as the device was knowingly used in a compromised condition.The complaint allegation that the device was received broken prior to use cannot be confirmed, as the customer-provided image shows apparent damage to the thread body, most likely resulting from use.

• Brand Name: BIO-COMPRESSION SCREW 3 X 18MM
• 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: 22675273
• Report Number: 1220246-2025-03163
• Device Sequence Number: 15687632
• Product Code: HWC
• UDI-Device Identifier: 00888867034693
• UDI-Public: (01)00888867034693(11)240205(17)260131(10)15202805
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060478
• 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): 11/06/2025

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 Expiration Date: 01/31/2026
• Device Model Number: BIO-COMPRESSION SCREW 3 X 18MM
• Device Catalogue Number: AR-5025B-18
• Device Lot Number: 15202805
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown