MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S1-2 9; TRAY, SURGICAL, INSTRUMENT

Model Number 71430401

Device Problem Crack (1135)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that, during a tka surgery, a gii ps hi flex isrt tr s1-2 9 was cracked and did not seat in tibia trial.Surgery was resumed, without any delay, with a sn back-up device.No harm to the patient or any further complications reported.

Manufacturer Narrative

H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned gii ps hi flex isrt tr s1-2 9 confirmed the device is broken in half and both pieces were returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Should 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.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT TR S1-2 9
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12598229
• MDR Text Key: 275412745
• Report Number: 1020279-2021-07477
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 03596010493019
• UDI-Public: 03596010493019
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71430401
• Device Catalogue Number: 71430401
• Device Lot Number: 10MM05642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Date Manufacturer Received: 10/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1