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	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/05/2024, it was reported by a arthrex employee via email that an ar-5207 tension lock collar was broken while malleting.This occurred during use in a case with no patient effect.
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 followup report will be submitted.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-5207 serial/batch number (b)(6) was received for investigation.The visual inspection indicated that the device's suture system was damaged; the tension collar outside diameter was broken off and cracked.Due to the device being damaged, no functional tests can be applied.The most likely cause for the reported failure is a user error.According to per dfu-0258-2.Revision 0.G.Precautions.1.Excessive force used in or during tensioning the device may cause damage to the device or suture construct.2.Measurement of the tunnel diameter and the proper implant selection are critical to maintain functionality of implant construct.3.Inserting the plug with excessive force may damage the device or suture construct.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18573892
• Report Number: 1220246-2024-00506
• Device Sequence Number: 8915133
• Product Code: HWC
• UDI-Device Identifier: 00888867265813
• UDI-Public: 00888867265813
• 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): 08/27/2024

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 7MM
• Device Catalogue Number: AR-5207
• Device Lot Number: 15129898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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