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

Model Number	FASTTHREAD INTERFERENCE SCRW DRIVER, 6MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2022-04275
• Device Sequence Number: 17077225
• Product Code: LXH
• UDI-Device Identifier: 00888867291928
• UDI-Public: 00888867291928
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown