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

Model Number	NX-4532K
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Align (2522); Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PHALANX BONE SCREW IMPLANT
• Manufacturer (Section D): NEXTREMITY SOLUTIONS, INC.; 210 north buffalo street; warsaw IN 46580
• MDR Report Key: 8392392
• Report Number: 3009540749-2019-00001
• Device Sequence Number: 19313111
• Product Code: HWC
• UDI-Device Identifier: 00817701020011
• UDI-Public: 00817701020011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: NX-4532K
• Device Lot Number: 168117318B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other