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

Model Number HT-0915

Device Problem Mechanical Jam (2983)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

The returned product was examined under magnification.The driver tip showed signs of wear across the faces of the hex where it would engage with screws.Some minor denting was seen around the edges of the hex tip.No other significant wear or damage was observed on the hex driver.The batch number of this driver corresponds to a revision of the part where a stick fit ramp feature was included.Additional mdrs associated with this event: 3025141-2021-00161: screw.

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.

• 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: 13124501
• MDR Text Key: 285393448
• Report Number: 3025141-2021-00160
• 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: 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

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HT-0915
• Device Catalogue Number: HT-0915
• Device Lot Number: 473208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian