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	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/23/2025, an arthrex subsidiary employee reported via email that an ar-5207 tensionloc collar and plug implant had a broken collar when inserted.The broken pieces were retrieved from the patient.The case was completed using another ar-5207 tensionloc collar and plug implant.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 -visual inspection of the tensionloc¿ collar and plug implant, 7mm was broken off and returned in many pieces.-functional testing was not performed due to the damage to the device.Per surgical technique tensionloc implant system #note: 7 place the impact driver into the collar with corresponding sutures exiting the collar through the impactor slots.Note the position of the slots and suture for insertion of the plug.Note: 8 insert the plug onto the impactor.Note the 12 o¿clock and 6 o¿clock suture orientation in conjunction with the impactor orientation slots the most likely cause of the reported failure is user error, which can be attributed to applying excessive mechanical forces upon insertion, misaligning the device during insertion, and/or prying/leveraging the device during 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: 22030371
• Report Number: 1220246-2025-02068
• Device Sequence Number: 18261680
• Product Code: HWC
• UDI-Device Identifier: 00888867265813
• UDI-Public: (01)00888867265813(11)250113(17)291231(10)15372194
• 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): 09/19/2025

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: 15372194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 04/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown