MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PLASTIC REAMTHRU FEM TRL SZ 6 RT; PROSTHESS, KNE,PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, PLYMER/METAL

Catalog Number	71436396
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the plastic trial broke when impacted.No delay, injury or back up reported.
Event or Problem Description
It was reported that during surgery the plastic trial broke when impacted.No delay, injury or back up reported.
Additional Manufacturer Narrative
The associated device for complaint c-0223190 was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured on both condyles next to the threaded inserts.The device was manufactured in 2017 and exhibits signs of moderate wear/usage.The device on complaint c-0223204 was not returned for evaluation.A review of complaint history for both devices did not reveal additional complaints for the listed batch.A review of the manufacturing records for both devices did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PLASTIC REAMTHRU FEM TRL SZ 6 RT
• Common Device Name: PROSTHESS, KNE,PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, PLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8190287
• Report Number: 1020279-2018-02869
• Device Sequence Number: 16650926
• Product Code: JWH
• UDI-Device Identifier: 00885556625873
• UDI-Public: 00885556625873
• Combination Product (Y/N): N
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2019

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 Catalogue Number: 71436396
• Device Lot Number: 17LB00414
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 12/04/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 12/28/2018; 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1