MAUDE Adverse Event Report: ACUMED LLC MINI ACUTRAK 2 DRILL, LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: DRILL

Model Number AT2M-L1813

Device Problem Dull, Blunt (2407)

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

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device returned to manufacturer in a loaner set before the complaint was filed.The device was discarded before it could be evaluated.

Event Description

While drilling the scaphoid with a mini acutrak 2 drill, long, the drill began to ship and would not move forward.Surgeon concerned the drill was dull.This issue caused a 45 minute delay in surgery.

• Brand Name: MINI ACUTRAK 2 DRILL, LONG
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: DRILL
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, or ; 6279957138
• MDR Report Key: 10173843
• MDR Text Key: 196413632
• Report Number: 3025141-2020-00150
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/08/2020

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
• Device Operator: Health Professional
• Device Model Number: AT2M-L1813
• Device Catalogue Number: AT2M-L1813
• Device Lot Number: 492463
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1