MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS ARCUS STAPLE SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Nextremity solutions became aware of this event during follow-up communications for reported event ref: 3009540749-2019-00015.During communications about the removed incore lapidus system.The reporter noted that an arcus staple was also removed during the same surgery at the request of the patient.There was no alleged or detected deficiency with the device.

Event Description

A patient was implanted with the incore lapidus system.Some time after surgery, it was reported that fusion was achieved and that the patient requested for the incore lapidus system to be removed because the post was "proud" and felt by the patient (ref: 3009540749-2019-00015).The patient also had an arcus staple implanted from a previous surgery and requested that the arcus staple be removed during the same surgery.

• Brand Name: ARCUS STAPLE SYSTEM
• Type of Device: STAPLE
• 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: elise fox ; 210 north buffalo street; warsaw, IN 46580 ; 5743762060
• MDR Report Key: 9331134
• MDR Text Key: 167976091
• Report Number: 3009540749-2019-00016
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K151160
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other