MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S3-4 9; TRAY, SURGICAL, INSTRUMENT

Model Number 71430408

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

Event Description

It was reported that during a tka procedure it was found that the genesis ii ps hi flex insert tr s3-4 9 was chipped.The surgery was finished with an s+n backup device.No injuries or surgical delays reported.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection confirmed the gii ps hi flex isrt tr s3-4 9 is chipped.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products 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.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Should 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 9
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10262235
• MDR Text Key: 198482400
• Report Number: 1020279-2020-03128
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 03596010493033
• UDI-Public: 03596010493033
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71430408
• Device Catalogue Number: 71430408
• Device Lot Number: 11BM09130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1