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	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a distributor reported via email that an ar-1570bc biocomposite-tenodesis screw (7 x 23 mm) broke while being tightened after being placed in the joint.Another implant was used to complete the procedure.This was discovered during a tendon transfer procedure on (b)(6) 2026.No harm to the patient was reported.
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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50474251
• Report Number: 1220246-2026-04508
• Device Sequence Number: 21431612
• Product Code: HWC
• UDI-Device Identifier: 00888867018945
• UDI-Public: (01)00888867018945(11)251013(17)290930(10)15512651
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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 Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1570BC
• Device Lot Number: 15512651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown