MAUDE Adverse Event Report: ARTHREX, INC. TENSIONLOC COLLAR AND PLUG IMPLANT 7MM; BONE FIXATION SCREW/PLATE

Model Number	TENSIONLOC COLLAR AND PLUG IMPLANT 7MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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 4/3/2025, it was reported by an arthrex employee via email that the collar from an ar-5207 tensionloc collar and plug cracked when the plug was hammered in.All the broken fragments were removed.The case was completed using another ar-5207 tensionloc collar and plug.This was discovered during a pcl reconstruction procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of fragments of an ar-5207, with batch number 15361486.Therefore, arthrex was able to deduce the most likely cause of the complaint.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.

• Brand Name: TENSIONLOC COLLAR AND PLUG IMPLANT 7MM
• 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: 21942112
• Report Number: 1220246-2025-01821
• Device Sequence Number: 8836525
• Product Code: HWC
• UDI-Device Identifier: 00888867265813
• UDI-Public: (01)00888867265813(11)241213(17)291130(10)15361486
• 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): 09/12/2025

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 7MM
• Device Catalogue Number: AR-5207
• Device Lot Number: 15361486
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown