MAUDE Adverse Event Report: ARTHREX, INC. FASTTHREAD INTERFERENCE SCRW DRIVER, 6MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number FASTTHREAD INTERFERENCE SCRW DRIVER, 6MM

Device Problem Dull, Blunt (2407)

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

Event Date 10/19/2021

Event Type  malfunction  

Event Description

It was reported that during an anterior cruciate ligament surgery multiple screw drivers were blunt.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.26-oct-2021 update: further information were provided that the reported event occurred during an anterior cruciate ligament repair and the screwdriver was twisted and not dull.During returned device evaluation, a reportable malfunction was discovered.

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the tip was found to be damaged and broken.The tip id is also obstructed with unknown white material.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: FASTTHREAD INTERFERENCE SCRW DRIVER, 6MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13225808
• MDR Text Key: 287179292
• Report Number: 1220246-2022-04275
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867291928
• UDI-Public: 00888867291928
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2022

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 Model Number: FASTTHREAD INTERFERENCE SCRW DRIVER, 6MM
• Device Catalogue Number: AR-4019D
• Device Lot Number: 47321824
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1