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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/14/2025, an arthrex subsidiary employee reported via email that an ar-5210 tensionloc¿ collar and plug implant had a fixation force that was weak and as a result could not be used.The case was completed by using another device from a different company.This was discovered during a case (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information received on 5/8/2025: this was discovered inside the patient during an acl procedure.The plug and collar did not fit well, and they could not be used.The case was not delayed, and additional anesthesia was not needed.
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 can be misuse due to improper bone preparation, misaligned insertion, or prying/leveraging the device during insertion.

• 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: 22001834
• Report Number: 1220246-2025-01990
• Device Sequence Number: 18423316
• Product Code: HWC
• UDI-Device Identifier: 00888867265820
• UDI-Public: (01)00888867265820(11)240826(17)290731(10)15307490
• 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,Followup
• Report Date (Section B): 10/09/2025

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: 15307490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: Not provided; 10/01/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/02/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown