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

Device Problem Difficult To Position (1467)

Patient Problem Injury (2348)

Event Date 03/23/2018

Event Type  Injury  

Event 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.

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
• Type of Device: PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7489673
• MDR Text Key: 107434683
• Report Number: 1020279-2018-00882
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010215574
• UDI-Public: 03596010215574
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 71440448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention