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

Catalog Number AR-3638

Device Problems Break (1069); Entrapment of Device (1212); Material Protrusion/Extrusion (2979)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/10/2018

Event Type  Injury  

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.The device was requested/is expected for evaluation but has not yet been received.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 Description

It was reported that during a hip arthroscopy procedure, the surgeon drilled and inserted the fibertak down the drill sleeve.When setting the fibertak and removing the anchor, 10mm of the tip of the driver shaft snapped and was lodged in the patient's acetabulum.The tip of the fragment was seen protruding out of the joint and the surgeon was able to break and remove that portion from the joint with a grasper, however, it was determined that there was still a fragment of the metal shaft lodged in the bone, but was not in the joint space.The surgeon decided to leave the fragment and move on with the repair with a different anchor (suturetaks).

• Brand Name: FIBERTAK
• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7398736
• MDR Text Key: 104419892
• Report Number: 1220246-2018-00115
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: 00888867292123
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: AR-3638
• Device Lot Number: S704611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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