MAUDE Adverse Event Report: ACUMED LLC 16.0MM, MICRO ACUTRAK 2® BONE SCREW; SCREW, FIXATION, BONE

Model Number AT2-C16-S

Device Problem Mechanical Jam (2983)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

While implanting a micro acutrak bone screw into the radial head, the driver tip became stuck in the screw head following insertion of the screw in the bone.When the driver was removed, the screw pulled out of the bone, refracturing the bone.

Manufacturer Narrative

The returned product was examined under magnification.The screw showed some minor signs of wear around the top face of the screw.Additionally, some of the screw threads showed areas where the anodization purple color had worn away and the remaining thread faces were silver and shiny.It is not possible to determine if these signs of wear were the result of implantation or from the screw pulling out of the bone.Additional mdrs associated with this event: 3025141-2021-00160: driver.

• Brand Name: 16.0MM, 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
• MDR Report Key: 13124499
• MDR Text Key: 285393512
• Report Number: 3025141-2021-00161
• 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: 12/09/2021

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-C16-S
• Device Catalogue Number: AT2-C16-S
• Device Lot Number: 500002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian