MAUDE Adverse Event Report: ACUMED LLC 14.0MM, MICRO ACUTRAK 2 BONE SCREW; SCREW, FIXATION, BONE

Model Number AT2-C14-S

Device Problems Failure to Advance (2524); Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

The returned screw was inspected under magnification.The screw over all is in good shape.All threading is still intact and the anodization is mostly present.Some anodization is missing, most likely from insertion.When compared to a new screw, the tip and cutting flutes are all visible.The screw was test inserted into a block of 30 pcf saw bone and had no issue cutting and inserting.

Event Description

A micro acutrak 2 was being implanted into to a patient.After being inserted half way, the screw stopped cutting into the bone and wouldn't advance.The screw was removed and a second screw was inserted all the way, smoothly.There was a 30 minute delay in surgery.

• Brand Name: 14.0MM, 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: 11770004
• MDR Text Key: 251797896
• Report Number: 3025141-2021-00038
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K944330
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AT2-C14-S
• Device Catalogue Number: AT2-C14-S
• Device Lot Number: 506666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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