MAUDE Adverse Event Report: ARTHREX INC. FIBERTAK DOUBLE LOADED FW CL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	AR-3600-2
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the driver tip broke-off in the patient.Patient was on the table at the time of call.Follow-up investigation: the surgeon was inserting an ar-3600-2 with the inserter instrument that comes with the anchor.The anchor was fully inserted but in the process of inserting the anchor, one of the prongs on the very distal nitinol tip of the inserter broke-off in the patient bone.The surgeon chose to leave the piece in the bone rather than damage bone attempting to remove the piece.The screw was left in place and used to complete the procedure.The inserter instrument was discarded at the time of procedure and is not available to return for evaluation.The procedure was a triceps repair.

• Brand Name: FIBERTAK DOUBLE LOADED FW CL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7398757
• Report Number: 1220246-2018-00121
• Device Sequence Number: 1221212
• Product Code: MBI
• UDI-Device Identifier: 00888867206960
• UDI-Public: 00888867206960
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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 Expiration Date: 03/01/2021
• Device Catalogue Number: AR-3600-2
• Device Lot Number: 10034976
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/05/2018
• 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