MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FIBERTAPE
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported by a patient's relative, via the arthrex website, that the female patient had a spine procedure years ago during which the surgeon used arthrex fibertape to soft fuse the spine.Patient has been experiencing great difficulties with scar tissue and reporter states the fibertape has failed.At the time of initial report no specific arthrex fibertape product number, surgeon name or facility information was provided.Additional information obtained 8/4/2020: patient underwent a c2-c7 spinal fusion procedure on (b)(6) 2016.Arthrex fibertape has been reported to have been used during the surgery.Specific part number is unknown at this time.The fusion performed by the surgeon failed and the patient underwent a revision procedure by a different surgeon.The revision was performed (b)(6) 2018.The patient is reported to still suffer from a lot of scar tissue in her spine that is pressing on her cord.Additional information obtained 8/5/2020: using the facility purchases of fibertape a most likely part number has been selected based on the date of purchase ((b)(6) 2016.The most likely part number to be reported will be ar-7237 (lot 10016315).

• Brand Name: FIBERTAPE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10442265
• Report Number: 1220246-2020-02080
• Device Sequence Number: 19446044
• Product Code: GAT
• UDI-Device Identifier: 00888867041738
• UDI-Public: 00888867041738
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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: 10/31/2020
• Device Model Number: FIBERTAPE
• Device Catalogue Number: AR-7237
• Device Lot Number: 10016315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other