MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL ALIGNMENT TUBE; PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR

Catalog Number	71440448
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tibial alignment guide couldn't be closed before fixing with pins, so the surgeon had proceed with a recut.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, it was reported that the surgeon fixed the block/kept it in the correct position and completed the procedure with a 3 to 5 minute surgical delay.The patient impact beyond the reported minimal surgical delay cannot be determined.No further medical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GII TIBIAL ALIGNMENT TUBE
• Common Device Name: PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7489673
• Report Number: 1020279-2018-00882
• Device Sequence Number: 13831205
• Product Code: MBH
• UDI-Device Identifier: 03596010215574
• UDI-Public: 03596010215574
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K121393
• 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
• Report Date (Section B): 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71440448
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention