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

Model Number	FIBERSTITCH RC, CURVED
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/23/2023, it was reported by a sales representative via email that a ar-19031c fiberstitch¿ implant broke.This occurred during a rotator cuff repair on (b)(6) 2023, the broken fragment was retrieved.No additional information provided.Additional information provided.
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
This is an oem device (private label) for which arthrex does not have the responsibility to file an adverse event.

• Brand Name: FIBERSTITCH RC, CURVED
• Common Device Name: 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: 16323583
• Report Number: 1220246-2023-06239
• Device Sequence Number: 5685225
• Product Code: MBI
• UDI-Device Identifier: 10818674027264
• UDI-Public: 10818674027264
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FIBERSTITCH RC, CURVED
• Device Catalogue Number: AR-19031C
• Device Lot Number: 22N05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown