MAUDE Adverse Event Report: ACUMED, LLC 22.0MM, MINI ACUTRAK 2® BONE SCREW; SCREW, FIXATION, BONE

Model Number AT2-M22-S

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

On 13 january 2023 acumed received a user facility medwatch report (report number (b)(4)).As reported on the medwatch form: "[redacted name] is a male who fractured his right wrist playing basketball in [redacted date].He underwent open reduction internal fixation in [redacted date], and revision surgery in [redacted date].His initial surgery was not with hss however his revision surgery with placement of a bone screw and kwire hardware took place on [redacted date] at hss nyc with dr.[redacted name].On [redacted date] the patient presented to hss, where dr.[redacted name] performed removal of right wrist hardware.Prior to the procedure, he noted that the pin had migrated slightly necessitating operative removal under anesthesia.The pin was removed successfully, however there were retained fragments identified by fluoroscopy following pin removal.Two minute fragments were left in place by dr.[redacted name] after extensive search and removal attempt rather than sustaining the risk of wider open operative dissection." the complaint pin/wire was reported to be a "microaire kirschner wire." additionally, an acumed screw was listed as "device #2" on the medwatch form.The batch/lot number provided on the medwatch form corresponds to a part number at2-m22-s, 2.0mm, mini acutrak 2® bone screw.Follow up with the user facility was conducted to obtain additional information about the event; however, these attempts were unsuccessful.It is unknown if there was any issue with the acumed screw involved in this event.The only information known based on what was reported is that the acumed screw was explanted.Exact implant and explant dates unknown.No further information is available.

Manufacturer Narrative

The device was not returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.Based on the information received, the root cause could not be determined.

• Brand Name: 22.0MM, MINI 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: 16297798
• MDR Text Key: 309184570
• Report Number: 3025141-2023-00026
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AT2-M22-S
• Device Catalogue Number: AT2-M22-S
• Device Lot Number: 459823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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
• Patient Age: 17 YR
• Patient Sex: Male