MAUDE Adverse Event Report: ACUMED, LLC MINI ACUTRAK 2® DRILL; BIT, DRILL

Model Number AT2M-1813

Device Problem Dull, Blunt (2407)

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

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.The returned product was inspected under magnification.Under magnification it was confirmed that the mini acutrak 2 drill (part number at2m-1813) had batch number 478407.Under magnification, it was noted the returned drill showed slight signs of wear.There was some slight deformation around the edges of the cannula at the tip of the drill and some very small dents on some of the cutting edges of the drill tip.Otherwise, no significant signs of damage or wear were observed along the length of the drill.It is possible that the damage observed dulled the drill, even when the denting and wear was slight.However, no definitive conclusion can be made.

Event Description

It was reported the drills were not sharp enough and a guide wire was broken during surgery.The piece of the tip of the broken guide wire was able to be removed, and there was nothing left in the patient's body.This report is related to report numbers 3025141-2022-00142 and 3025141-2022-00143 which are for the other devices involved in this event.

• Brand Name: MINI ACUTRAK 2® DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 14430986
• MDR Text Key: 294672015
• Report Number: 3025141-2022-00141
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AT2M-1813
• Device Catalogue Number: AT2M-1813
• Device Lot Number: 478407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• 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