MAUDE Adverse Event Report: ARTHREX, INC. FIBERSTITCH IMPLANT, CURVED; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERSTITCH IMPLANT, CURVED
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
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 that two curved fiberstitch implants, ar-4570, were being used in a procedure.First device, was utilized exactly like the technique requires; however, the second implant would not kick out of the trocar.The surgeon re-inserted and it still would not kick out of the sheath.The suture was cut and the debris removed.The second device, was deployed just as the first.No fault, no issue.Operation was smooth.The first loop was reduced, but upon reducing the second loop, the device locked and would not tighten down to the meniscus.The sutures were cut, excess was cleaned up and no harm was done to the patient.Additional information provided: 01/03/2020: the implants from both devices were left behind in the patient (4 total), but the suture between both implants was cut out.A left notch shoulder cutter was used and a shaver to removed all debris.

• Brand Name: FIBERSTITCH IMPLANT, CURVED
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9607421
• Report Number: 1220246-2020-01587
• Device Sequence Number: 504137
• Product Code: MBI
• UDI-Device Identifier: 10818674021798
• UDI-Public: 10818674021798
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K190125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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: 04/30/2024
• Device Model Number: FIBERSTITCH IMPLANT, CURVED
• Device Catalogue Number: AR-4570
• Device Lot Number: 19N04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other