MAUDE Adverse Event Report: FLOWER ORTHOPEDICS MFP 012; MTP PLATE, LEFT

Catalog Number	MFP 012
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Patient Problem/Medical Problem (2688)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed.The original lot number of the plate was 1610300030.There were no anomalies.From the x-rays, the plate broke where there would be the highest stress.The patient displayed a malunion.The bones were not fused.The plate broke after a year of withstanding in-vivo forces.Upon review of the x-rays from a second doctor, dr.(b)(6) said: "it's too plantarflexed.The distal screw is barely biting anything and the d to p screw is too close to the joint", which created a situation where fusion would be unlikely.Therefore the root cause of the plate breakage was due to surgeon technique.A report was conducted regarding the blackness around the plate, the report determined that it was "not" "metalosis" nor infection, it was just black pigment.(b)(4).
Event or Problem Description
Mtp plate(mfp 012, lot 1701320000) implanted on (b)(6) 2018 broke; revision surgery happened on (b)(6) 2019.During the removal, there was also a report of blackness surrounding the plate, which the doctor believed could be "metalosis".

• Brand Name: MFP 012
• Common Device Name: MTP PLATE, LEFT
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd.; suite 280; horsham PA 19044
• MDR Report Key: 8271301
• Report Number: 3009996260-2019-00001
• Device Sequence Number: 117264
• Product Code: HRS
• UDI-Device Identifier: 00840118105019
• UDI-Public: 840118105019
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: MFP 012
• Device Lot Number: 1701320000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/23/2019
• 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
• Patient Age: 75 YR