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

Model Number FIBERSTITCH IMPLANT, CURVED

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2019

Event Type  Injury  

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 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
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 9607421
• MDR Text Key: 189490915
• Report Number: 1220246-2020-01587
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10818674021798
• UDI-Public: 10818674021798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other