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 Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tka surgery the bottom of gii ps hi flex isrt tr s3-4 11 was found to be chipped.No delay.Procedure was finished using a s&n back up device.No injuries reported.
Additional Manufacturer Narrative
The associated device, intended to use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Based on this investigation, the need for corrective action is not indicated.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated 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.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 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 S3-4 11
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10262216
• Report Number: 1020279-2020-03123
• Device Sequence Number: 2617392
• Product Code: FSM
• UDI-Device Identifier: 03596010493040
• UDI-Public: 03596010493040
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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
• Device Lot Number: 07CM18887
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1