MAUDE Adverse Event Report: ACUMED LLC 20.0MM, MICRO ACUTRAK 2 BONE SCREW; SCREW, FIXATION, BONE

Model Number AT2-C20-S

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the micro acutrak 2 screw showed minimal wear across the cannulated surface or the threads.There was some visible wear in the corners of the hex recess.Functional test exhibited that the drivers are able to interface with a screw and be removed successfully.Additional mdrs associated with this event: 3025141-2021-00075: driver.

Event Description

A surgeon inserted a acutrak 2 mini screw into a bone to treat a fracture.When the surgeon tried to pull the driver from the screw head, the driver stuck and pulled the screw from the bone, attached to the driver.

• Brand Name: 20.0MM, MICRO ACUTRAK 2 BONE SCREW
• 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 ; 8886279957
• MDR Report Key: 12199847
• MDR Text Key: 264739968
• Report Number: 3025141-2021-00074
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K944330
• 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: 07/02/2021

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: AT2-C20-S
• Device Catalogue Number: AT2-C20-S
• Device Lot Number: 474771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• 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