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); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The device history record review revealed nothing relevant to the event.If the device is returned and additional information is obtained, a follow-up report 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 thumb ucl repair procedure, the bone was drilled to its full depth on the 1.35 mm kwire into a later 40's female bone, which was not remarked as being of better or worse than usual quality to be found in a patient of this demographic.The anchor was begun to be seated with the clear sleeve not being retracted from the anchor at all.The anchor was turned one to two full turns before the malfunction was observed and the anchor head fully detached from the inserter.The piece was recovered and the anchor and broken piece were disposed of.The surgeon then opted to drill bone tunnels and pass sutures through the bone to be tied on the radial aspect of the thumb necessitating another incision.

• 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: 7600189
• MDR Text Key: 111009861
• Report Number: 1220246-2018-00229
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• 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: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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