MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S1-2 11; TRAY, SURGICAL, INSTRUMENT

Model Number 71430402

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Event Description

It was reported that gii ps hi flex isrt tr s1-2 11 has developed a chip on the guide in the bottom.No case involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the device has multiple scratches, burrs, deep gouges in the plastic.There is a piece of the device missing and was not returned with the device.This device show extreme signs of wear/usage.This device was manufactured in 2005.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• Brand Name: GII PS HI FLEX ISRT TR S1-2 11
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10449583
• MDR Text Key: 204239135
• Report Number: 1020279-2020-04188
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 03596010493026
• UDI-Public: 03596010493026
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71430402
• Device Catalogue Number: 71430402
• Device Lot Number: 05BM18505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1