MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS ARCUS STAPLE SYSTEM

Model Number ARC-1008K

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

The drill and guide bushing were compared with print specifications and found to be conforming.Device history records related to the event were reviewed.There were no non-conformance's detected through the device history record review.A supplemental report will be filed if new information is obtained which changes the investigation results.

Event Description

It was reported that during a surgery with the arcus staple system, the drill was stuck in the guide and the guide proceeded to whip around the drill.The surgeon grabbed a hold of the guide to stabilize it, and removed the drill from the guide.Surgeon manually marked where to drill on the patients bone and drill was used without the guide to complete the surgery.No patient impact was 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: denise holloway ; 210 north buffalo street; warsaw, IN 46580 ; 7323837901
• MDR Report Key: 10573837
• MDR Text Key: 208140954
• Report Number: 3009540749-2020-00032
• Device Sequence Number: 1
• Product Code: JDR
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARC-1008K
• Device Lot Number: 168525817D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 08/24/2020
• 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