MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, BIOCOMPOSITE; BONE FIXATION SCREW/PLATE

Model Number	TENODESIS SCREW, BIOCOMPOSITE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/21/2025, an arthrex subsidiary employee reported via email that an ar-1555bc biocomposite-tenodesis screw 5.5 x 15 mm broke easily at the moment it was introduced into the joint.The case was completed, and the broken piece was retrieved from the patient.This was discovered during a shoulder arthroscopy procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 08/27/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Complaint allegation is not confirmed.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 a most likely cause.Per dfu-0111-eo - g.Precautions - 6.Bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.
Event or Problem Description
Additional information received on 9/4/2025: the case was completed using another ar-1555bc biocomposite-tenodesis screw.The case was not delayed, and additional anesthesia was not needed.The patient did not suffer any adverse event on or after the surgery.

• Brand Name: TENODESIS SCREW, BIOCOMPOSITE
• 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: 23004236
• Report Number: 1220246-2025-03767
• Device Sequence Number: 15832430
• Product Code: HWC
• UDI-Device Identifier: 00888867018853
• UDI-Public: (01)00888867018853(11)250109(17)281231(10)15371034
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K051726
• 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,Followup
• Report Date (Section B): 11/07/2025

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: TENODESIS SCREW, BIOCOMPOSITE
• Device Catalogue Number: AR-1555BC
• Device Lot Number: 15371034
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown