MAUDE Adverse Event Report: ARTHREX, INC. TENSIONLOC COLLAR AND PLUG IMPLANT 10MM; BONE FIXATION SCREW/PLATE

Model Number	TENSIONLOC COLLAR AND PLUG IMPLANT 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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 08/05/2025, an arthrex subsidiary employee reported via email that an ar-5210 tensionloc collar and plug implant had an issue when the collar was inserted; it sank into the bone, causing damage around the collar.All broken pieces were removed from the patient.The case was completed using a replacement ar-5210 tensionloc collar and plug implant.This issue was discovered during an acl reconstruction procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 08/13/2025: there was no significant case delay, and no additional anesthesia was administered.No adverse effects were reported.Additional information was received on 08/21/2025: it was further clarified that the damage was limited to the device and that the patient's bone tissue remained unaffected.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.Dfu-0258-2 : excessive force used in or during tensioning the device may cause damage to the device or suture construct.The complaint allegation could not be confirmed as the device was not received for investigation.

• Brand Name: TENSIONLOC COLLAR AND PLUG IMPLANT 10MM
• 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: 22888663
• Report Number: 1220246-2025-03631
• Device Sequence Number: 14687368
• Product Code: HWC
• UDI-Device Identifier: 00888867265820
• UDI-Public: (01)00888867265820(11)241223(17)291130(10)15365380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183628
• 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): 12/17/2025

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: TENSIONLOC COLLAR AND PLUG IMPLANT 10MM
• Device Catalogue Number: AR-5210
• Device Lot Number: 15365380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown