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	05/25/2021
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
It was reported that the ar-5207 tensionloc collar, was used in acl reconstruction.When the collar was fixed to the bone hole using a silicon hammer and the plug of the product was inserted into the collar, the collar of the plug joint broke causing the product to become unusable.The surgeon could not remove the plug, and the plug is still left in the patient.The surgery was completed using a product from another manufacturer.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that only three fragments of the collar were returned.No damage was noted to the returned plug.The root cause is undetermined, however the most likely causes are improper bone prep, misaligned insertion, prying and/or leveraging the device during insertion.

• 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
• MDR Report Key: 11991234
• Report Number: 1220246-2021-03273
• Device Sequence Number: 3564725
• Product Code: HWC
• UDI-Device Identifier: 00888867265813
• UDI-Public: 00888867265813
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: TENSIONLOC COLLAR AND PLUG IMPLANT 7MM
• Device Catalogue Number: AR-5207
• Device Lot Number: 10454813
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1