MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II C/R FEM SIZE 3 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420004
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon was opening the first box, the second one stuck to the first one and was torn off.The surgeon did not want to use this prosthesis.It is unknown when the event occured, if there was backup from s+n available and if there was a delay.
Additional Manufacturer Narrative
Results of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The outer tyvek lid was stuck to the inner tyvek lid causing the inner lid to tear when the outer lid was opened.Both lids appeared to have a complete seal, so the sterile barrier was not compromised.The device was manufactured in 2020.A review of complaint history did not reveal additional complaints for the listed batch.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 reason to suspect that the product failed to meet product specifications at the time of manufacture.This event appears to be isolated at this time.The potential probable cause for this event is a manufacturing process error.Previous actions were taken to reduce the reoccurrence of this failure mode.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: GNS II C/R FEM SIZE 3 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10421463
• Report Number: 1020279-2020-04009
• Device Sequence Number: 11510897
• Product Code: JWH
• UDI-Device Identifier: 03596010205421
• UDI-Public: 03596010205421
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420004
• Device Catalogue Number: 71420004
• Device Lot Number: 20BM06108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1