MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS INCORE LAPIDUS SYSTEM; BONE SCREW

Catalog Number	IC-LAP-3542
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Nextremity solutions became aware of this complaint when an employee heard a sales representative mention an incore removal.During follow-up communication with the sales representative, it was reported that the patient was walking (full weight bearing) on the foot before healing, which does not align with the post-operative instructions prescribed by the surgeon or the instructions for use for the incore lapidus system.The surgeon attributed the break to this circumstance.There is no alleged or detected deficiency with the device.
Event or Problem Description
A patient was implanted with the incore lapidus system (left post, 3.5mm x 32mm screw, 3.5 x 42mm screw).After surgery, the 3.5mm x 42mm screw broke at the junction with the post.All pieces of the incore lapidus system were removed per the surgical technique.The surgeon used bone filler and a plate after removing incore.

• Brand Name: INCORE LAPIDUS SYSTEM
• Common Device Name: BONE SCREW
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• MDR Report Key: 9268802
• Report Number: 3009540749-2019-00010
• Device Sequence Number: 2616435
• Product Code: HWC
• UDI-Device Identifier: 00817701021032
• UDI-Public: 00817701021032
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: IC-LAP-3542
• Device Lot Number: R17295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 11/01/2019
• 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: Required Intervention