MAUDE Adverse Event Report: ACUMED, LLC T8 STICK FIT HEXALOBE DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 80-0759

Device Problem Break (1069)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.The t8 stick fit hexalobe driver (part number 80-0759, batch number 579620) was returned for evaluation.The returned driver was visually examined under magnification and had physical batch number 579620.The driver showed signs of twisting of the lobes on the tips.The twisted lobes on the driver are indicative of this excessive force that was applied.The returned product description indicated the drivers were damaged during removal.However, based on the information received and due to unknown surgical conditions, the root cause could not be determined.

Event Description

It was reported during removal surgery that the driver tip broke.The screw was removed with a carbide drill from another company.The surgery was completed after a 20-minute delay.There were no other adverse patient consequences reported.This report is related to report number 3025141-2024-00272 for the screw involved in this event.

• Brand Name: T8 STICK FIT HEXALOBE DRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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
• MDR Report Key: 18959651
• MDR Text Key: 338441077
• Report Number: 3025141-2024-00271
• Device Sequence Number: 1
• Product Code: LXH
• 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,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80-0759
• Device Catalogue Number: 80-0759
• Device Lot Number: 579620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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 Race: Asian