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	03/23/2022
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 (b)(6) 2022, it was reported by an arthrex employee via email that an ar-3602-2 fibertak inserter broke when the anchor was being inserter into the patient.Broken pieces were not retrieved and everything remains in the patient, as case was completed using the device.This occurred during a rcr procedure (b)(6) 2022.However; during the procedure, surgeon was unaware the inserter broke in the patient.No further information has been given at this time.Arthrex employee cannot verify whether the fibertak was from lot number 10149849 or 10401372.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that a portion of the inserter is missing.The piece was not returned for investigation.The breakage point was noted to be smooth.The length was measured and 2.2 inches of the inserter shaft was found to be missing.The cause of this remains undetermined.

• 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: 14136489
• Report Number: 1220246-2022-04751
• Device Sequence Number: 17370752
• Product Code: MBI
• UDI-Device Identifier: 00888867206953
• UDI-Public: 00888867206953
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown