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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 2/16/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1998 cannulated screwdriver shaft broke during use.The case was completed using another screwdriver.All the broken fragments were removed.This was discovered during a procedure on (b)(6) 2024.Additional information requested.Additional information provided 2/21/24: the procedure performed was an anterior ligament reconstruction.The surgery was completed without additional anesthesia.The patient had no negative effects.
Additional Manufacturer Narrative
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 was able to conclude a most likely cause.The method used to prepare the bone, was not provided.The most likely cause is attributed to misuse due to use error of over-torquing/over-engaging the driver with 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: jared engle ; 8009337001
• MDR Report Key: 18827346
• Report Number: 1220246-2024-01265
• Device Sequence Number: 18112730
• Product Code: LXH
• UDI-Device Identifier: 00888867025790
• UDI-Public: 00888867025790
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Model Number: SCREWDRIVER SHAFT, CANN, 3.5MM HEX
• Device Catalogue Number: AR-1998
• Device Lot Number: 10053993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2016
• 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