MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL ALIGNMENT TUBE; PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRAIND,UNCMNTD,PR,CTD,PLYMR/MTL/PLYMR

Catalog Number	71440448
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tibial alignment guide pieces are not connecting correctly.There was no patient injury.
Additional Manufacturer Narrative
The associated complaint devices was returned and evaluated.A visual examination of the returned gii tibial alignment tubes indicated moderate damage from wear/use.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.A functional evaluation indicated that the failure mode could not be verified as all returned devices function as intended with functional/dimensional gages.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII TIBIAL ALIGNMENT TUBE
• Common Device Name: PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRAIND,UNCMNTD,PR,CTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7604393
• Report Number: 1020279-2018-01124
• Device Sequence Number: 16493077
• Product Code: MBH
• UDI-Device Identifier: 03596010215574
• UDI-Public: 03596010215574
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 71440448
• Device Lot Number: 17GTD0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1