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 Information (3190)
Date of Event	12/31/2019
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 a curved fiberstitch implant, ar-4570, was being used during a knee arthroscopy procedure.When the second implant was deployed behind the capsule, the implant stayed on the needle and the needle came out of the fiberstitch handle.The fiberstitch handle was removed per technique.The patient wasn't harmed and the needle was removed from the patient without causing any damage.Additional information provided 01/07/2020: the first implant was not removed and remained in the capsule.The case was completed with a device from another manufacturer.

• 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: 9631367
• Report Number: 1220246-2020-01603
• Device Sequence Number: 11556125
• Product Code: MBI
• UDI-Device Identifier: 10818674021798
• UDI-Public: 10818674021798
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/27/2020

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: 19N06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/27/2020
• 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