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	Insufficient Information (4580)
Date of Event	08/13/2025
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
It was reported that the device broke.No further information was received.Update (b)(6) 27-aug-25: more information was provided.It was reported that during a reconstruction surgery of the achilles tendon, the surgeon lost grip during placement of the screw.He then checked the ankle and saw that the screw was broken.After that he tried to retrieve the screw, but only the top came off, so he left the a part in the patient.The bone was quite soft so it¿s strange that it broke.The surgery was finished successfully by placing a short screw on top of the broken screw.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-complaint allegation is confirmed.-visual inspection of the biocomposite-tenodesis¿ screw 7 x 23 mm, identified that the distal end of the screw was broken off.-functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for 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.

• 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: 23015974
• Report Number: 1220246-2025-03804
• Device Sequence Number: 18584218
• Product Code: HWC
• UDI-Device Identifier: 00888867018945
• UDI-Public: (01)00888867018945(11)250313(17)290228(10)15404059
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1570BC
• Device Lot Number: 15404059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown