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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 08/14/2023, it was reported by an arthrex employee via email that an ar-5210 tensionloc collar and plug could not be secured after implantation.This was discovered during a tibal fixator for aclr procedure on (b)(6) 2023.A new product was used to complete the case.Additional information received on 8/23/2023: after the graft was implanted and passed through the tensionloc collar, there was a loss in fixation, and the plug could not be secured.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-5210 with the tensionloc plug were received for evaluation.Visual evaluation noted nicks on the threads of the tensionloc collar.No issues found with the tensionloc plug.No functional testing performed.No bone information was provided.The most likely cause for the reported event is a user error.Per tensionloc surgical technique.Features and benefits.Strong initial fixation maintains graft tension for final fixation.Step 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.9.With the leg in full extension, tension the sutures and insert the plug (a guidewire may be used) between the sutures until the plug is flush with the surrounding collar.Tie a surgeon¿s knot vertically into the plug slot for final fixation.Note: all plug, suture, and impactor slots must be oriented at 12 o¿clock and 6 o¿clock to provide optimum fixation.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17710215
• Report Number: 1220246-2023-07821
• Device Sequence Number: 6749017
• Product Code: HWC
• UDI-Device Identifier: 00888867265820
• UDI-Public: 00888867265820
• 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): 11/06/2024

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: 15086765
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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