MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK WITH SUTURETAPE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERTAK WITH SUTURETAPE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2020
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 during an (b)(6) 2020 extensive interior anterior and posterior labral repair procedure in a patient's right shoulder, the following occurred: an ar-3602 fibertak with 1.3mm suturetape was inserted into the shoulder, according to proper technique, using a tight curve drill guide and the appropriate drill bit.The anchor was placed at the 4 o'clock position on the glenoid.After drilling the socket, the surgeon maintained the proper position for the drill guide, while the assistant inserted the anchor into the drill guide and proceeded to mallet the anchor into the socket until the piston of the inserter was flush with the back of the drill guide.No unusual occurrences or abnormalities were noticed as the anchor was being placed.The anchor was then passed, tied and cut in the usual fashion.No abnormalities were noted at the time.The surgery was completed and the patient was sent home until their two week follow-up appointment.During the follow up x-rays were taken and it was discovered that approximately 6mm of the ar-3602 anchor inserter tip was retained in the glenoid of the patient.This was reported to the arthrex sales rep (b)(6) 2020.It is unknown if the staff checked all inserters/instruments after use in the procedure.Inserters were discarded at time of procedure.At time of initial report the surgeon has not decided whether or not to remove the retained piece of the anchor inserter.It is unknown which of the two ar-3602 lot numbers used during the procedure was the one which left the fragment.The lot numbers used during the procedure were lot 10984886 and lot 11145747.

• Brand Name: FIBERTAK WITH SUTURETAPE
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10884504
• Report Number: 1220246-2020-02365
• Device Sequence Number: 16951362
• Product Code: MBI
• UDI-Device Identifier: 00888867206946
• UDI-Public: 00888867206946
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151230
• 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): 11/23/2020

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 Model Number: FIBERTAK WITH SUTURETAPE
• Device Catalogue Number: AR-3602
• Device Lot Number: UNK SEE EVENT DESCRIPTION
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/23/2020
• 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