MAUDE Adverse Event Report: FLOWER ORTHOPEDICS BONE SCREW, D:3.5MM X L:55.0MM

Catalog Number	FBS 355
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Fbs 355 screw head broke while dr.(b)(6) was trying to reduce the plate onto the bone using the screw.The screw head was explanted and the screw body was left within the patient.The patient was not harmed and the screw would not be explanted in the future.

• Brand Name: BONE SCREW, D:3.5MM X L:55.0MM
• Common Device Name: BONE SCREW
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd.; suite 280; horsham PA 19044
• MDR Report Key: 7105534
• Report Number: 3009996260-2017-00008
• Device Sequence Number: 11071478
• Product Code: HWC
• UDI-Device Identifier: 00840118100465
• UDI-Public: 840118100465
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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: Physician
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: FBS 355
• Device Lot Number: 2014002403
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/11/2017
• 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