MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LINER REMOVAL TOOL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71366021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during thr surgery, tip of the r3 liner removal tool was chipped.The device was located outside the patient at the moment of the issue.The procedure was completed using a competitor device.Surgery was less than or equal to 30mins delayed.Patient was not harmed.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.It has been confirmed that the device damage was noticed before the surgery and did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.
Event or Problem Description
It was reported that during thr surgery, tip of the r3 liner removal tool was chipped.The issue was noticed before the procedure.The procedure was completed using a competitor device.Surgery was less than or equal to 30mins delayed.Patient was not harmed.

• Brand Name: R3 LINER REMOVAL TOOL
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16301824
• Report Number: 1020279-2023-00270
• Device Sequence Number: 15190225
• Product Code: JDG
• UDI-Device Identifier: 03596010580184
• UDI-Public: 03596010580184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: 71366021
• Device Catalogue Number: 71366021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 02/04/2023
• Supplement Report FDA Received Date: 03/13/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown