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	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
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 (b)(4) 2023, it was reported by an arthrex employee via email that an ar-5210 collar and plug implant broke.This occurred during a case on (b)(6) 2023, during insertion a portion of the collar was broken.All fragments of the broken device were retrieved.The case was completed using another ar-5210.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, the screw was broken on the threads in three pieces.Shows marks of deep scratch around the edges of the device.The most likely cause is that the tensionloc plug was over-torqued with the impact driver and broke the tensionloc collar.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 17030504
• Report Number: 1220246-2023-06811
• Device Sequence Number: 17757293
• Product Code: HWC
• UDI-Device Identifier: 00888867265820
• UDI-Public: 00888867265820
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 05/17/2024

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: 15030822
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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