MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SLT 3 MOD TIB CUTBLCK LT; PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR

Catalog Number 71440209

Device Problem Difficult To Position (1467)

Patient Problem Injury (2348)

Event Date 03/23/2018

Event Type  Injury  

Event Description

It was reported that during surgery is difficult to fix tibial cutting block in correct position, so the surgeon had to 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.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.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.

• Brand Name: GII SLT 3 MOD TIB CUTBLCK LT
• 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: 7489671
• MDR Text Key: 107434678
• Report Number: 1020279-2018-00883
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010460431
• UDI-Public: 03596010460431
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71440209
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: No
• 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