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

Model Number FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Discharge (2225)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded by the facility.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the patient underwent a proximal biceps tenodesis repair procedure on (b)(6) 2018.During this procedure, a fibertak double loaded w/ 1.3 suturetape, ar-3602-2, was implanted.Soon after the procedure, the patient began to experience pain at the incision site.On (b)(6) 2018, the patient was seen at his surgeon¿s office for a washout of the wound.The surgeon stated that the wound began to ¿weep¿.The surgeon has stated that he will remove the implants, however, a date of surgery for the revision has not been scheduled as of yet.Pending additional information.Additional information provided on 6/26/2018: the surgeon explanted the ar-3602-2 on (b)(6) during the patient's visit and discarded.He did not replace it with anything else, he left it as is.

• Brand Name: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: 7685062
• MDR Text Key: 113883467
• Report Number: 1220246-2018-00542
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867206953
• UDI-Public: 00888867206953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2018

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
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Model Number: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• Device Catalogue Number: AR-3602-2
• Device Lot Number: 10032630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/13/2018
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other