MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL PATELLA {} 5 PT. SZ GDE; PROSTHESISKNEEFEMOROTIBIALSEMICONSTRAINEDCEMENTEDMETALPOLYMER

Model Number	71440842
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, three (3) gii oval patella 5 pt.Sz gde are missing a size that was broken off.Each sizing guide is missing one size.As this was notice during field inspection, not patient was involved.
Additional Manufacturer Narrative
H3, h6 the associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The devices were found to be fractured along the one of the arms, rendering the devices inoperative.The devices show signs of extensive use.A review of complaint history of the previous 12 months revealed similar events for the listed devices, this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to these devices and failure mode.A contribution of the devices to the reported event could be corroborated as the devices show signs of damage/wear.This devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII OVAL PATELLA {} 5 PT. SZ GDE
• Common Device Name: PROSTHESISKNEEFEMOROTIBIALSEMICONSTRAINEDCEMENTEDMETALPOLYMER
• 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
• MDR Report Key: 14279552
• Report Number: 1020279-2022-02064
• Device Sequence Number: 5337173
• Product Code: HRY
• UDI-Device Identifier: 03596010485045
• UDI-Public: 03596010485045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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
• Device Model Number: 71440842
• Device Catalogue Number: 71440842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown