MAUDE Adverse Event Report: ARTHREX, INC. SCREWDRIVER SHAFT, CANN, 3.5MM HEX; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCREWDRIVER SHAFT, CANN, 3.5MM HEX
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-1998 cannulated screwdriver shaft twisted while removing a titanium interference screw.This was discovered during a revision acl procedure on (b)(6) 2023.The screw was finally removed with a product from another manufacturer.No further information has been provided.Additional information received on (b)(6) 2023: the sales representative does not know when the original procedure occurred but was told it was performed over thirteen years ago.The original procedure was performed by a different surgeon at a different facility.The part number for the screw is also unknown, the sales representative believes it could have been an ar-1370h-25 soft screw, 7x 25 mm, or an ar-1380h-25 soft screw, 8 x 25 mm.The revision surgeon was performed because the patient tore the acl.During the revision surgery, only the femoral screw was removed, as the tibial screw was not in the way to perform the revision surgery.The surgeon used (2) ar-4020c-08 fastthread biocomposite interference screw 8 x 20 mm during the revision surgery.One in the femur and the other in the tibia.The revision surgery was only delayed a few minutes as the surgeon needed to remove the screw.The case was completed successfully, and the patient suffered no negative effect on or after the procedure.
Additional 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation was confirmed based on the customer's attached picture (img_1036.Jpg), which displays the screwdriver tip damaged.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported and observed failure is user error.Specifically, the error involved applying excessive force, leading to over-torquing or over-engaging the driver within the screw head.

• Brand Name: SCREWDRIVER SHAFT, CANN, 3.5MM HEX
• Common Device Name: 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: emily shafer ; 8009337001
• MDR Report Key: 18295937
• Report Number: 1220246-2023-09313
• Device Sequence Number: 18001659
• Product Code: LXH
• UDI-Device Identifier: 00888867025790
• UDI-Public: 00888867025790
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: SCREWDRIVER SHAFT, CANN, 3.5MM HEX
• Device Catalogue Number: AR-1998
• Device Lot Number: 364052
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown