MAUDE Adverse Event Report: ACUMED, LLC 12.0MM, MICRO ACUTRAK 2® BONE SCREW; SCREW, FIXATION, BONE

Model Number AT2-C12-S

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 03/22/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.The returned 12.0mm, micro acutrak 2® bone screw was examined visually under magnification.There appeared to be scratches on the screw head and white/tan material between the threads at the tip.Functional tests exhibited that both returned drivers can be inserted and removed from the screw by hand.Sticking of the drivers was confounded due to the twist in the hex tips.Due to unknown procedural conditions, no definitive conclusion on the cause of the incident can be made.

Event Description

It was reported that during the procedure when the surgeon removed the screwdriver from the screw after inserting the screw, the screw was pulled out from the bone due to the strong fixing force between the screw and the screwdriver.The screw was used for the talus.Because of the larger hole in the bone, the surgeon could no longer use the micro screws.Therefore, he switched to the mini screw.This report is related to report numbers 3025141-2022-00104 and 3025141-2022-00105 which are for the other devices involved in this event.

• Brand Name: 12.0MM, 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: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 14162198
• MDR Text Key: 289680325
• Report Number: 3025141-2022-00106
• Device Sequence Number: 1
• Product Code: HWC
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AT2-C12-S
• Device Catalogue Number: AT2-C12-S
• Device Lot Number: 478345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Race: Asian