MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PLATE, MTP FUSION, 5 DEG, MED, RIGHT

Catalog Number	MPP1005R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a patient underwent a metatarsal-phalangeal joint (mtp) arthrodesis procedure on (b)(6) 2018 and when the patient returned to the doctor for a follow up appointment on 3/27/2019 it was noted that the implanted plate was broken.The broken plate was noticed when the follow-up x-ray was performed.There was no obvious impact to the fusion that was performed and the patient was asymptomatic.The plate remained implanted with no surgical intervention performed related to the broken plate.There was no report of any adverse patient consequence or effect on the patient's fusion as a result of the incident.There was no serious injury, follow-up medical care or medical intervention required.The device is not being returned to medline for evaluation.A root cause could not be determined at this time.The doctor reported that the patient was moderately compliant with post-operative instruction other than transitioning back to normal shoes too early.No additional information is available at the time of this report.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that during a patient's three month follow up visit with the doctor the implanted metatarsal-phalangeal joint (mtp) fusion plate was noted during x-ray to be broken.

• Common Device Name: PLATE, MTP FUSION, 5 DEG, MED, RIGHT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8486594
• Report Number: 1417592-2019-00042
• Device Sequence Number: 19272797
• Product Code: HRS
• UDI-Device Identifier: 10888277363946
• UDI-Public: 10888277363946
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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: Health Professional
• Device Catalogue Number: MPP1005R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/05/2019
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 100