MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HOUSING RESECT COLLET S3-8; PROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY

Model Number 71434424

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 01/21/2020

Event Type  Injury  

Event Description

It was reported that during a tka procedure, the collet popped off while he was reaming for the box.The doctor almost took off his finger today as the collet popped off while he was reaming for the box.The surgery was completed with the same device.There were no delays in the procedure and no patient injuries were reported.

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 the surgeon was not injured at all, 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: LGN HOUSING RESECT COLLET S3-8
• Type of Device: PROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9734877
• MDR Text Key: 180566222
• Report Number: 1020279-2020-00650
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010549327
• UDI-Public: 03596010549327
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71434424
• Device Catalogue Number: 71434424
• Device Lot Number: 18KCW1013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention