MAUDE Adverse Event Report: ARTHREX INC. NANO CORKSCREW FT, TI, W 3-0 FW; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number AR-1317FT

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/28/2018

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.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 additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that during a case, the surgeon was using the nano corkscrew for the first time and as he was inserting the corkscrew into the carpal bone, the anchor made a pop noise.He decided to use the anchor and as he tensioned the sutures they pulled out of the anchor and failed.When he checked x ray, the anchor broke.Follow-up investigation: anchor part number was ar-1317ft, lot 10175216.The anchor broke on the ordinal end of the anchor during the last turn.The anchor stayed in and was tied down securing the tendon.Then the surgeon tested motion and the sutures broke.The sutures were removed and the top portion of the broken anchor was removed from the patient.The remaining portion of the broken anchor was left in the patient.Another manufacturer's anchor was then implanted to finish the case.X-rays were not available.The procedure was an fdp avulsion.

• Brand Name: NANO CORKSCREW FT, TI, W 3-0 FW
• 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: 7467831
• MDR Text Key: 106702144
• Report Number: 1220246-2018-00150
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867276703
• UDI-Public: 00888867276703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180118
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: AR-1317FT
• Device Lot Number: 10175216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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