MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE, BEVELED FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number DRIVER, T10 HEXALOBE, BEVELED FT

Device Problem Break (1069)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a mica surgery the screw driver broke outside the patient.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update swit 27-mar-2024: it was confirmed that the device broke outside the patient.There was no harm for patient.

• Brand Name: DRIVER, T10 HEXALOBE, BEVELED FT
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19090703
• MDR Text Key: 340048807
• Report Number: 1220246-2024-01992
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867362635
• UDI-Public: 00888867362635
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRIVER, T10 HEXALOBE, BEVELED FT
• Device Catalogue Number: AR-8741-40
• Device Lot Number: 1392245
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1