MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL ALIGNMENT TUBE; PRSTHSIS,KNEE,PTLLO/FMROTIBL,SMICNSTRAIND,UNCMNTD,PRS,COATD,POLYMR/MTAL/POLYMR

Catalog Number	71440448
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tibial cutting jig is not function properly.
Additional Manufacturer Narrative
The gii alignment tube was returned and evaluated.A visual inspection found no obvious sign of damage.Additionally, a functional check found that the device worked as intended.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A review of the complaint history revealed no additional complaints for the associated lot number.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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,PTLLO/FMROTIBL,SMICNSTRAIND,UNCMNTD,PRS,COATD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8072037
• Report Number: 1020279-2018-02487
• Device Sequence Number: 14023265
• 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): 12/27/2018

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
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1