MAUDE Adverse Event Report: FLOWER ORTHOPEDICS CORP. 1.7MM ANGLED & INCLINED PLATE; ORTHOPEDIC BONE FIXATION PLATE

Catalog Number MFP 012

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

Upon interview with physician it was confirmed that the technique outlined in the technique guides associated with the named prodcut (mfp 012) was not followed in this instance.In particular, it was noted that the physician use only one 4.0mm cannulated screw in combination with the plate construct, while it is recommended in the technique guide to place two 3.0mm cannulated screws in combination with the plate construct.Device not returned.

Event Description

Flower orthopedics was informed on (b)(6) 2015, that the physician had determined the implanted plate, mfp 012 (1.7mm angled and inclined plate, titanium), had broken while still implanted inside the patients foot.Also on (b)(6) 2015, it was reported that a revision surgery was scheduled for (b)(6) 2015, to remove the broken plate.The flower orthopedics implant construct was placed on (b)(6) 2015 in order to support the fusion of the patient's mtp joint in the foot.The patient's joint had not yet fully fused, and would also not be expected to be fully fused at the time of the revision surgery date (5 weeks post original surgery, (b)(6) 2015), so no further injury was sustained by the patient.

• Brand Name: 1.7MM ANGLED & INCLINED PLATE
• Type of Device: ORTHOPEDIC BONE FIXATION PLATE
• Manufacturer (Section D): FLOWER ORTHOPEDICS CORP.; 100 witmer road; suite 280; horsham PA 19044
• Manufacturer (Section G): FLOWER ORTHOPEDICS CORP.; 100 witmer road; suite 280; horsham PA 19044
• Manufacturer Contact: alyssa schwartz ; 100 witmer road; suite 280; horsham, PA 19044 ; 2153234017
• MDR Report Key: 5223551
• MDR Text Key: 31178562
• Report Number: 3009996260-2015-00002
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 008401181050198
• UDI-Public: (01)008401181050198(17)200901(10)2013204091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2015

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
• Device Operator: Physician
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: MFP 012
• Device Lot Number: 2013204091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 84