MAUDE Adverse Event Report: ACUMED, LLC 1.5MM CANNULATED HEX DRIVER ASSEMBLY; SCREWDRIVER

Model Number HD-1509

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.No ncmrs or additional complaints have been assigned to this batch number.The returned driver was visually inspected and the prior revisions were reviewed to confirm the complaint.The driver tip (batch 465193) was in good condition with no damage noted.When tested in the returned screws, it was difficult to remove the screws due to the stick fit geometry of the driver tip.The stick fit geometry was added to hd-0915 on (b)(6) 2014 which is the subcomponent of the assembly hd-1509.The stick fit was removed on (b)(6) 2021.This particular driver was manufactured on 21 march 2019 which means it would have the stick fit feature on the driver tip.The driver is functioning as intended per the print revision.

Event Description

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".This happened with two screws.This report is on the driver.This is related to report number: 3025141-2022-00040 which is on one of the screws involved in this event and report number 3025141-2022-00041 which is on the second screw involved in this event.

• Brand Name: 1.5MM CANNULATED HEX DRIVER ASSEMBLY
• Type of Device: SCREWDRIVER
• 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: 13641459
• MDR Text Key: 289175134
• Report Number: 3025141-2022-00039
• Device Sequence Number: 1
• Product Code: HXX
• 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: 03/01/2022

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: HD-1509
• Device Catalogue Number: HD-1509
• Device Lot Number: 465193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Race: Asian