MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PLATE, MTP FUSION, 0 DEG, SML, RIGHT

Catalog Number	MPP1001R
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was undergoing a routine 6 month follow up x-ray after a right foot metatarsal-phalangeal joint (mtp) arthrodesis and a broken mtp plate was discovered at that time.The mtp plate was originally implanted in the patient on (b)(6) 2017.Reportedly, the surgeon did not feel that the patient's non-union was a result of the broken plate, but was a result of the patient's own biology.On an unknown date, approximately six months after the initial mtp plate placement, the patient underwent an additional procedure to remove the broken plate and place another mtp plate for fusion, without further incident reported.No additional information is available.The customer returned the broken plate for evaluation; however, a root cause could not be determined.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 routine patient follow up the implanted plate was broken.

• Common Device Name: PLATE, MTP FUSION, 0 DEG, SML, RIGHT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8302789
• Report Number: 1417592-2019-00016
• Device Sequence Number: 13468803
• Product Code: HRS
• UDI-Device Identifier: 10888277363786
• UDI-Public: 10888277363786
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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 Catalogue Number: MPP1001R
• Device Lot Number: 924802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2019
• 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: 56 YR