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

Model Number	TENSIONLOC COLLAR AND PLUG IMPLANT 7MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/05/2021
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 10/05/2021 it was reported by a arthrex employee via email that an ar-5207 tensionloc collar broke.This occurred during an acl reconstruction.The case was completed using a new product.There was no patient effect reported.Additional information requested.Additional information provided 10/05/2021 the device broke in the patient, all fragments were removed.The case was completed using a new ar-5207.

• Brand Name: TENSIONLOC COLLAR AND PLUG IMPLANT 7MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 12738629
• Report Number: 1220246-2021-03878
• Device Sequence Number: 4815769
• 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): 11/02/2021

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 Expiration Date: 11/30/2025
• Device Model Number: TENSIONLOC COLLAR AND PLUG IMPLANT 7MM
• Device Catalogue Number: AR-5207
• Device Lot Number: 12300016
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/02/2021
• Date Device Manufactured: 12/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown