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

Model Number	NX-3532K-SC
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The proximal screw used in the (b)(6) 2019 surgery remained implanted and was successfully used with a replacement middle implant on (b)(6) 2019.Successful usage of the original proximal screw with a second middle implant indicates the dislocation was not a result of a defect with the proximal screw.The suspect middle screw returned to nextremity solutions inc.Was visually reviewed and functionally tested with a proximal screw, the same part number used in the (b)(6) 2019 surgery.The middle and proximal implants locked together as designed and intended.The functional review revealed no defect with the middle screw.The device history record for the suspect middle implant lot was reviewed.The device history record revealed that appropriate inspection was completed which verified the middle screws met print and that the product was made from compliant materials and conformed to all specifications.Device history records for all kits which are composed of the suspect lot of middle screws were also reviewed and found to meet nextremity solutions inc.'s receiving inspection.Nextremity solutions inc.'s complaint history was reviewed for identification of trends.There are no other complaints for the specific lots involved in (b)(4).Complaints involving kits containing middle screws were reviewed to determine if there is a trend for dislocated nextra devices involving the middle screw.There were zero other complaints which reported dislocation due to middle screws.There are no trends identified.Review of the device history records, review previous complaints, and the passed functional test of the suspect middle screw indicates the dislocation was not a result of a defect with the middle screw.
Event or Problem Description
The patient underwent hammertoe surgery on (b)(6) 2019.After surgery, x-rays showed the implant had dislocated.The patient came back into the doctor's office the following day for the surgeon to attempt to fix the dislocation.This was not successful.The patient was scheduled for surgery on (b)(6) 2019, at which point the surgeon removed the dislocated 3.5mm middle implant.The surgeon implanted a 4.5 middle implant to replace the implant.This was successful.

• 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: 8422053
• Report Number: 3009540749-2019-00002
• Device Sequence Number: 2051082
• Product Code: HWC
• UDI-Device Identifier: 00817701020059
• UDI-Public: 00817701020059
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 168110917B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/14/2019
• 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
• Patient Age: 61 YR