MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S5-6 11; TRAY, SURGICAL, INSTRUMENT

Model Number 71340416

Device Problems Crack (1135); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that one (1) genesis ii posterior stabilized high flexion insert trial size 1-2 9mm, 1 genesis ii posterior stabilized high flexion insert trial size 5-6 11mm, 1 genesis ii posterior stabilized high flexion insert trial size 7-8 9mm, 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 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.

Manufacturer Narrative

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.

• Brand Name: GII PS HI FLEX ISRT TR S5-6 11
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12643363
• MDR Text Key: 276854065
• Report Number: 1020279-2021-07591
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 03596010329011
• UDI-Public: 03596010329011
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71340416
• Device Catalogue Number: 71430416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1