MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS NEXTRA HAMMERTOE CORRECTION SYSTEM; BONE SCREW

Model Number	NX-3532K-SC
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received which changes the outcome of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a surgery with the nextra hammertoe correction system the proximal implant would not sit flat on the screwdriver.A second screwdriver was opened to complete the surgery.There were no reported patient complications.

• Brand Name: NEXTRA HAMMERTOE CORRECTION SYSTEM
• Common Device Name: BONE SCREW
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• MDR Report Key: 9578284
• Report Number: 3009540749-2020-00005
• Device Sequence Number: 2902022
• Product Code: HWC
• UDI-Device Identifier: 00817701020059
• UDI-Public: 00817701020059
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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-3532K-SC
• Device Lot Number: 168125017B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1