MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS ARCUS STAPLE SYSTEM

Model Number	ARC-1310K
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is obtained which changes the outcome of the investigation, a follow-up report will be filed.
Event or Problem 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
• Common Device Name: STAPLE
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• MDR Report Key: 9592632
• Report Number: 3009540749-2020-00006
• Device Sequence Number: 10844768
• Product Code: JDR
• UDI-Device Identifier: 00817701020196
• UDI-Public: 00817701020196
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151160
• 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): 01/15/2019

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: ARC-1310K
• Device Lot Number: 168525417A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 87