MAUDE Adverse Event Report: FLOWER ORTHOPEDICS CORP. CANNULATED DRIVER; SCREWDRIVER

Catalog Number	GWK 100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Gwk 100 cannulated driver broke during ipj fusion.The cannulated driver was inserting a 20 mm cannulated screw over the guidewire when the cannulated driver tip broke off.

• Brand Name: CANNULATED DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): FLOWER ORTHOPEDICS CORP.; 100 witmer rd; suite 280; horsham PA 19044
• MDR Report Key: 6211026
• Report Number: 3009996260-2016-00006
• Device Sequence Number: 553331
• Product Code: HXX
• UDI-Device Identifier: 00840118110822
• UDI-Public: 840118110822
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2016

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: No Information
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: GWK 100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 12/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other