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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an eclipse with universal glenoid surgery the screwdriver broke off when tightening the screw.A part of the device was still in the screw head.The inlay recess was raised, as the screw head was minimally protruding.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged driver shaft, ar-9545-t15-01, serial/batch number (b)(6), was received for investigation.The visual inspection revealed that the driver's distal tip was twisted/stripped.Due to the device's damage, functional testing was not performed.The most likely cause is misuse, which can be attributed to improper bone preparation, misaligned insertion, or prying/leveraging the device during insertion.

• 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: 20159133
• Report Number: 1220246-2024-07434
• Device Sequence Number: 8301232
• Product Code: LXH
• UDI-Device Identifier: 00888867225183
• UDI-Public: 00888867225183
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 1392115
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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