MAUDE Adverse Event Report: ARTHREX, INC. TORPEDO, CURVED, HL 4.2MM X 19CM; SAW BLADE

Model Number	TORPEDO, CURVED, HL 4.2MM X 19CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the patient¿s legal representative, the tip of a torpedo shaver broke off during a left hip labrum repair surgery on (b)(6) 2022.It is alleged that the providers were unaware of the broken fragment, which was left unretrievable in the joint space.Thereafter, the patient was experiencing pain and locking of his hip.Accordingly, an mri was attempted on (b)(6) 2023, but aborted due to machine malfunction (apparently due to the metal fragment within the hip).A ct scan was performed instead, and the retained metal fragment in the hip was discovered.A second surgery was performed on (b)(6) 2023, for retained fragment removal and a total hip arthroplasty.The second surgery was performed by a different surgeon at another facility, and the implants were another manufacturer¿s devices.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
Additional information received on 10/21/2024: the part number or the shaver torpedo is ar-6420ctd from lot number 14924482.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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 most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: TORPEDO, CURVED, HL 4.2MM X 19CM
• Common Device Name: SAW BLADE
• 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: 18921595
• Report Number: 1220246-2024-01518
• Device Sequence Number: 7738628
• Product Code: GFA
• UDI-Device Identifier: 00888867273894
• UDI-Public: (01)00888867273894(11)220210(17)270131(10)14924482
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TORPEDO, CURVED, HL 4.2MM X 19CM
• Device Catalogue Number: AR-6420CTD
• Device Lot Number: 14924482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 05/05/2025
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 11/07/2024; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown