MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S5-6 9; TRAY, SURGICAL, INSTRUMENT

Model Number 71430415

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 surgery the plastic of the gii ps hi flex isrt tr s5-6 9 was found to be chipped.No delay.Procedure was finished using a s&n back up.No injuries reported.

Manufacturer Narrative

The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is chipped and has signs of wear and tear from use.The device was manufactured in 2008.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints 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 device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/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 actions are being taken at this time.

• Brand Name: GII PS HI FLEX ISRT TR S5-6 9
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10262214
• MDR Text Key: 198483434
• Report Number: 1020279-2020-03125
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 03596010493057
• UDI-Public: 03596010493057
• 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: 12/08/2020

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: 71430415
• Device Catalogue Number: 71430415
• Device Lot Number: 08EM06638
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1