MAUDE Adverse Event Report: FLOWER ORTHOPEDICS CORP. CANNULATED DRILL BIT 2.6MM

Catalog Number	CDB 026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The cannulated drill bit snapped in half during implantation.The shards were irretrievable and left inside bone of the patient.

• Brand Name: CANNULATED DRILL BIT 2.6MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): FLOWER ORTHOPEDICS CORP.; 100 witmer road; suite 280; horsham PA 19044
• MDR Report Key: 5836591
• Report Number: 3009996260-2016-00005
• Device Sequence Number: 465990
• Product Code: HTW
• UDI-Device Identifier: 00840118106689
• UDI-Public: 840118106689
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 10/30/2020
• Device Catalogue Number: CDB 026
• Device Lot Number: 2013005688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2016
• Initial Report FDA Received Date: 08/01/2016
• 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: Required Intervention