MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS ARCUS STAPLE SYSTEM

Model Number ARC-1310K

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a surgery with the arcus staple system, the drill was tight in the drill guide and the drill guide bent.Drilling was able to be completed.A staple was placed and the surgeon attempted to use the staple inserter as a tamp.The surgeon could not re-engage the inserter with the staple.This occured with two different staples and inserters and the staple could not be fully seated against the bone.The surgeon removed the arcus staple and completed the surgery with a max vpc screw.There were no patient complications reported.

• 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 ; 5743762062
• MDR Report Key: 9592632
• MDR Text Key: 200662519
• Report Number: 3009540749-2020-00006
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00817701020196
• UDI-Public: 00817701020196
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARC-1310K
• Device Lot Number: 168525417A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2019
• 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 Age: 61 YR
• Patient Weight: 87