MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE FT; WASHER, BOLT, NUT

Model Number	MINI TIGHTROPE FT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hallux valgus correction surgery the anchor tore out of the bone.After the surgeon was able to fixate the implant on the metatarsal the button became loose.The surgeon was able to retrieve the button and the sutures but the anchor remained inside the patient.The surgeon was finished with a different device which was placed more distal.
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.
Additional Manufacturer Narrative
Complaint is not confirmed.Visual inspection identified that no anchor or photo provided was returned for investigation of the 3.5 mm mini tightrope¿ ft.The button returned had scratched, and no issue was found with the driver.The method used to prepare the bone, as well as the bone quality encountered, were not recorded.Functional testing was not performed due to the missing components.

• Brand Name: MINI TIGHTROPE FT
• Common Device Name: WASHER, BOLT, NUT
• 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: 18456620
• Report Number: 1220246-2024-00163
• Device Sequence Number: 16919282
• Product Code: HTN
• UDI-Device Identifier: 00888867048959
• UDI-Public: 00888867048959
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090107
• 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): 06/06/2024

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: MINI TIGHTROPE FT
• Device Catalogue Number: AR-8917DS
• Device Lot Number: 15105889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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