MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; BONE FIXATION SCREW/PLATE

Model Number	TENO SCRW,BIO-COMP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 09-feb-2026, an arthrex subsidiary employee reported via email that an ar-1547bc biocomposite-tenodesis screw 4.75 x 15 mm broke upon insertion and began to back out.No additional anesthesia was administered.The procedure was completed using two ar-4020c-07 biocomposite fastthread fastthread biocomposite interference screw 7 x 20 mm (batches 15468502 and 15426402).The issue occurred during an acl reconstruction on (b)(6) 2026.No patient harm was reported.Additional information was received on 16-feb-2026: there was no case delay.A photo was provided showing the detached screw fragments; however, it has not been confirmed whether all fragments were retrieved from the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: TENO SCRW,BIO-COMP
• 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: 24429742
• Report Number: 1220246-2026-00887
• Device Sequence Number: 21393334
• Product Code: HWC
• UDI-Device Identifier: 00888867018778
• UDI-Public: (01)00888867018778(11)220408(17)260331(10)14948705
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 06/22/2026

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: 03/31/2026
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1547BC
• Device Lot Number: 14948705
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown