MAUDE Adverse Event Report: ACUMED LLC 27.0MM ACUTRAK® FUSION DEVICE; SCREW, FIXATION, BONE

Model Number ATF-270-S

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 11/15/2021

Event Type  malfunction  

Event Description

An acutrak fusion device was being used in an orthopedic surgery.The part seemed "off" and it was not functioning properly.The screw would not seat correctly - the diameter seemed to be the issue and the surgeon could not widen due to the patient's bone.The device was scrapped.There was a 20 minute delay in surgery as a result.

• Brand Name: 27.0MM ACUTRAK® FUSION DEVICE
• Type of Device: SCREW, FIXATION, BONE
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5032071387
• MDR Report Key: 12978922
• MDR Text Key: 284304838
• Report Number: 3025141-2021-00148
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ATF-270-S
• Device Catalogue Number: ATF-270-S
• Device Lot Number: 453304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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