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

Model Number 80-0759

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

1 of 3 it was reported during a removal surgery that the surgeon broke the driver tip.The screw was removed using a carbide drill from another company.The surgery was completed after a 30-minute delay.There were no other adverse patient consequences reported.There are 3 related report numbers for this event 3025141-2024-00068 through 3025141-2024-00070.

Manufacturer Narrative

The reported screw was not returned for evaluation.Additionally, manufacturing and inspection records could not be reviewed as the model number and batch/lot number of the screw is unknown.However, the reported drivers were returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.The two t8 stick fit hexalobe driver (part number 80-0759, batch numbers 564223 and 597180) were returned for evaluation.The returned drivers were examined under magnification.One driver (part number 80-0759, batch number 564223) showed no signs of wear and engaged with a screw.The second driver (part number 80-0759, batch number 597180) had a broken tip.It cannot be determined at what point the driver broke.However, based on the information received and due to unknown surgical conditions, the root cause could not be determined.

• 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: 18748025
• MDR Text Key: 335878262
• Report Number: 3025141-2024-00168
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 564223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Date Manufacturer Received: 01/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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