MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE SYNDESMOSIS REPAIR CANNULATED; WASHER, BOLT, NUT

Model Number	TIGHTROPE SYNDESMOSIS REPAIR CANNULATED
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The sister of the patient contacted arthrex on (b)(6) 2017 regarding a reaction and pain of an arthrex implant in the patient¿s knee.The incident was initially entered in the old arthrex complaint system creekside with reference number cc109970.A statement was provided by the sister of the affected patient and the surgeon which slightly deviated from the provided information of the patient¿s sister on (b)(6) 2017.The information was initially provided and documented in cc109970 and are disposed in the notes of this case.On (b)(6) 2023 the sister of the patient contacted arthrex again with the following complaint.Due to ongoing complications, pain, state of constant inflammation and infection the patient decided to reach out to a new surgeon requesting a removal of the implant.The patient underwent an additional surgery to remove the implant on (b)(6) 2017.The surgeon of the additional operation did not know the exact placement of the implant, because the information could not be provided from the first surgeon.It is not sure if all fragments of the implant could be retrieved from the knee, but the ct scan and ultrasound are not showing left pieces inside the patient.To this day the patient is experiencing low grade fever, constant pain, decreased mobility and constant infections.There is a loss on the fibular joint as the implant went through the soft tissue and into the bone.
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
Additional information: the complaint is not confirmed based on the customer provided x-ray/ct scan, which displays the device in the knee.Infection/inflammation cannot be seen in the attached x-rays or ct scans.Per instruction from the product management team, this device is only recommended to be used in the ankle.No change in harm was identified.

• Brand Name: TIGHTROPE SYNDESMOSIS REPAIR CANNULATED
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16906786
• Report Number: 1220246-2023-06711
• Device Sequence Number: 6837265
• Product Code: HTN
• UDI-Device Identifier: 00888867048980
• UDI-Public: 00888867048980
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: TIGHTROPE SYNDESMOSIS REPAIR CANNULATED
• Device Catalogue Number: AR-8920CDS
• Device Lot Number: 12728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown