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

Catalog Number	115035
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2019-01822
• Device Sequence Number: 19335625
• Product Code: MBH
• UDI-Device Identifier: 03596010052063
• UDI-Public: 03596010052063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 115035
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1