MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE 2.0/2.4MM CANNULATED SCREW DRIVER BIT; SCREWDRIVER

Catalog Number 210-24-003

Device Problem Material Integrity Problem (2978)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported by independent sales representative, the driver broke when the dr had the screw halfway into bone.She heard a crack and metal broke off the driver and was unable to capture the screw head.There was a delay in the case to try and find a solution.The explanted screws were discarded.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Instrument failure - 20 minute delay in surgery.

• Brand Name: 2.0/2.4MM CANNULATED SCREW DRIVER BIT
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston, TX 77007
• Manufacturer (Section G): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston, TX 77007
• Manufacturer Contact: justin lovelace ; 727 north shepherd drive; suite 100; houston,, TX 77007
• MDR Report Key: 19056509
• MDR Text Key: 340449683
• Report Number: 3007420745-2024-00001
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00812926021393
• UDI-Public: 00812926021393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D300093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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 Catalogue Number: 210-24-003
• Device Lot Number: TSL016232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/06/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female