MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURF PAT TRIAL 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71430432

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

It was reported that, three (3) patella trials gii oval resurf pat trial 35mm, gii oval resurf pat trial 29mm and gii oval resurf pat trial 32mm, have deep scratches and small chunks missing.As this was noticed upon field inspection, there was not patient involvement.

Manufacturer Narrative

H6: the device, intended for use in treatment, was returned for evaluation.A visual inspection confirms deep gouges/burrs and scratches.The instrument exhibits significant amount of use and wear.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 review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.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 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 OVAL RESURF PAT TRIAL 32MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12164317
• MDR Text Key: 261453663
• Report Number: 1020279-2021-05928
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010484925
• UDI-Public: 03596010484925
• Combination Product (y/n): N
• PMA/PMN Number: K150241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71430432
• Device Catalogue Number: 71430432
• Device Lot Number: 15KM01280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1