MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF DISTAL CUT BLK; PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR

Catalog Number 71441147

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

Event Type  malfunction  

Event Description

It was reported that during surgery, the pin which was used combination with the cutting block was stuck into the hole of the cutting block.A delay was reported of less than 30 minutes.No back-up was available.

Manufacturer Narrative

The gii distal cutting block was returned and evaluated.A visual inspection found burs on the cutting guide slot and light scratches in one of the pin guide holes.A functional inspection also found that observed damage will not allow a pin go through as intended.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.The complaint history revealed no additional complaints for this device.Additionally, a review of 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.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that no back-up was available but surgery was completed with the same device, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GII MIS DCF DISTAL CUT BLK
• Type of Device: PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8146799
• MDR Text Key: 129788458
• Report Number: 1020279-2018-02731
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010497185
• UDI-Public: 03596010497185
• 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,Followup
• Report Date: 01/16/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71441147
• Device Lot Number: 15JM11736
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 11/13/2018; 11/28/2018
• Supplement Dates FDA Received: 01/02/2019; 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1