MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 9/26/2022, it was reported by a sales representative via email that an ar-3602-2 fibertak suture anchor broke upon insertion.This was discovered during an unspecified procedure on (b)(6) 2022.Additional information received on 9/26/2022: this was discovered during an open subscap procedure.The shaft of the inserter broke off from the red handle.All broken pieces were removed from the patient and case was completed using another ar-3602-2 fibertak suture anchor.No further issues has been reported.

• Brand Name: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• 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: 16052008
• Report Number: 1220246-2022-05992
• Device Sequence Number: 15002680
• Product Code: MBI
• UDI-Device Identifier: 00888867206953
• UDI-Public: 00888867206953
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181769
• 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
• Report Date (Section B): 12/27/2022

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: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• Device Catalogue Number: AR-3602-2
• Device Lot Number: 14796033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 12/27/2022
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown