MAUDE Adverse Event Report: ARTHREX, INC. 4.5 BIOCOMPOSITE FT WITH NEEDLES; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	4.5 BIOCOMPOSITE FT WITH NEEDLES
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
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 during a rotator cuff repair procedure, the ar-1927bcnf-45 (lot: 11576124) broke when it was about halfway inserted and could not be retrieved.An arthrex sales representative was not present during the procedure.The surgeon informed the rep that they were able to alter their technique and complete the case as scheduled.

• Brand Name: 4.5 BIOCOMPOSITE FT WITH NEEDLES
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11393330
• Report Number: 1220246-2021-02635
• Device Sequence Number: 14232449
• Product Code: MAI
• UDI-Device Identifier: 00888867096875
• UDI-Public: 00888867096875
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4.5 BIOCOMPOSITE FT WITH NEEDLES
• Device Catalogue Number: AR-1927BCNF-45
• Device Lot Number: 11576124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1