MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, SHORT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T-15, SHORT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed, the drive feature is twisted but not broken.It is stated a torque indicating device was not used, which is recommended to prevent damaging the device.The most likely cause for the reported failure can be attributed to user error of the device due to over-torqueing/over-engaging the driver with the screw head.
Event or Problem Description
It was reported during a revision rsa, all four t15 driver bits twisted and warped while trying to remove the 6.5mm central screw of the universal convertible baseplate.Peripheral screws removed fine but the central screw would not move, and the bits would twist before the screw would move.Central screw was removed by using a different driver bit.See source data and image attached.The part number(s) of explanted product is currently unknown.Additional information received on 3/8/21: the rep reported the primary procedure took place approximately four years ago at the same facility where the revision was performed.The revision surgery took place due to pain and possible infection.The rep reported they are unable to provide the part and lot numbers of explanted product.

• Brand Name: DRIVER SHAFT, T-15, SHORT
• 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: 19547227
• Report Number: 1220246-2024-05868
• Device Sequence Number: 4734996
• Product Code: LXH
• UDI-Device Identifier: 00888867225183
• UDI-Public: 00888867225183
• 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
• Report Date (Section B): 06/17/2024

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: DRIVER SHAFT, T-15, SHORT
• Device Catalogue Number: AR-9545-T15-01
• Device Lot Number: 8001602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2021
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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