MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S3-4 11; TRAY, SURGICAL, INSTRUMENT

Model Number	71430409
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one (1) genesis ii posterior stabilized high flexion insert trial size 1-2 9mm, one (1) echelon 260mm porous bowed femoral component standard collar size 16 left, one (1) genesis ii posterior stabilized high flexion insert trial size 7-8 9mm, one (1) genesis ii posterior stabilized high flexion insert trial size 7-8 11mm, one (1) genesis ii posterior stabilized high flexion insert trial size 5-6 9mm and one (1) genesis ii posterior stabilized high flexion insert trial size 3-4 11mm are cracked and worn.As this was noticed upon inspection, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable, damage may occur during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT TR S3-4 11
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12314295
• Report Number: 1020279-2021-06317
• Device Sequence Number: 3839134
• Product Code: FSM
• UDI-Device Identifier: 03596010493040
• UDI-Public: 03596010493040
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 71430409
• Device Catalogue Number: 71430409
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1