MAUDE Adverse Event Report: ACUMED LLC 3.5MM X 16MM NON-LOCKING HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 30-0259

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2021-00101: driver 1, 3025141-2021-00102: driver 2, 3025141-2021-00103: driver 3, 3025141-2021-00104: driver 4, 3025141-2021-00105: driver 5, 3025141-2021-00108: screw 2.

Event Description

While implanting hexalobe screws into a patient's bone during an orthopedic surgery, the hexalobe driver did not engage the screws.Two drivers (same batch number) were found to have the problem.A different batch number of drivers was successfully located and used.This resulted in a 15 minute delay in surgery.Note: five drivers were returned - 2 had been used in this surgery.The other three are from this batch but had never been used.

• Brand Name: 3.5MM X 16MM NON-LOCKING HEXALOBE SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• MDR Report Key: 12663906
• MDR Text Key: 279929029
• Report Number: 3025141-2021-00107
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30-0259
• Device Catalogue Number: 30-0259
• Device Lot Number: 521672
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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