MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEX SCREWDRIVER; PROSTHE,KNEE,PAT/FEMTIBIAL,SEMICONSTRAINED,UNCEM,POROUS,COATED,POLY/MET/POLY

Catalog Number 115035

Device Problem Connection Problem (2900)

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

Event Date 04/04/2019

Event Type  malfunction  

Event Description

It was reported that during the case, surgeon tried making an adjustment to the 5-in-1 cutting block and the handle was spinning out, not gripping the screwdriver.A competitor synthes universal screwdriver was used in lieu and the case was completed without any harm or delay involved.

Manufacturer Narrative

The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: HEX SCREWDRIVER
• Type of Device: PROSTHE,KNEE,PAT/FEMTIBIAL,SEMICONSTRAINED,UNCEM,POROUS,COATED,POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8592161
• MDR Text Key: 144458232
• Report Number: 1020279-2019-01822
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010052063
• UDI-Public: 03596010052063
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115035
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1