MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS, INC. NEXTRA HAMMERTOE CORRECTION SYSTEM; PHALANX BONE SCREW IMPLANT

Model Number NX-4532K

Device Problems Mechanical Problem (1384); Failure to Align (2522); Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records revealed no production anomalies.Nextremity solutions, inc.Made good faith effort to provide information for return and to request return of the product involved in this event.The parts were not returned to the manufacturer and there for no evaluation of the parts was conducted.

Event Description

The surgeon reported failure of the female(proximal) 4.5mm nextra component to engage with the male (middle) component on two separate nx-4532k devices within the same surgery.The surgery was completed successfully after the reported device failures.A surgical delay of greater than 30 minutes was reported.

• Brand Name: NEXTRA HAMMERTOE CORRECTION SYSTEM
• Type of Device: PHALANX BONE SCREW IMPLANT
• Manufacturer (Section D): NEXTREMITY SOLUTIONS, INC.; 210 north buffalo street; warsaw IN 46580
• Manufacturer Contact: elise fox ; 210 north buffalo street; warsaw, IN 46580 ; 5743762062
• MDR Report Key: 8392392
• MDR Text Key: 137938010
• Report Number: 3009540749-2019-00001
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00817701020011
• UDI-Public: 00817701020011
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX-4532K
• Device Lot Number: 168117318B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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