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

Catalog Number IC-LAP-28L

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is obtained which changes the outcome of the investigation results, a follow up report will be submitted.

Event Description

During a surgery on (b)(6) 2021 using the incore lapidus system it was discovered that the drill bushing tube would not allow the drill to pass through.In order to properly use the drill bushing the surgeon chose to drill through the drill bushing which subsequently resulted in metal fragments around the surgical site.Surgeon reported all fragments were removed.A new drill bit was opened to complete the surgery.Delay of surgery was less than 15 minutes.No further patient complications were reported.

• Brand Name: INCORE LAPIDUS SYSTEM
• Type of Device: SCREW
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• Manufacturer (Section G): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• Manufacturer Contact: denise holloway ; 210 north buffalo street; warsaw, IN 46580 ; 7323837901
• MDR Report Key: 11526563
• MDR Text Key: 242969867
• Report Number: 3009540749-2021-00005
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IC-LAP-28L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention