MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO STR MTP PLT,SHT,TI; PLATE, FIXATION, BONE

Model Number	LO-PRO STR MTP PLT,SHT,TI
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Device disposition is unknown.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported, via a patient letter received 9/26/18, that the patient had a foot procedure in (b)(6) 2017 during which an arthrex ar-8944-p (low profile straight mtp plate) was implanted and in (b)(6) 2017 it was discovered the plate had cracked in half.Patient stated that post op the original (b)(6) 2017 procedure she was wearing a medical boot and following all instructions by her doctor.Patient suffered from pain and swelling and was referred to a foot surgeon specialist who had to remove the broken plate and insert another plate to ensure that the foot healed properly.Additional information obtained 9/26/18: in (b)(6) 2017, patient underwent a bunion procedure which did not fuse.The surgeon, then performed a second procedure (b)(6) 2017.During the second procedure an ar-8944-p (low profile straight mtp plate) was implanted.Patient had been wearing a medical boot and following all post-op protocol.In (b)(6) 2017 patient went for a follow up to determine if the boot could come off and an x-ray discovered that the plate had cracked inside her foot.Patient was then referred to a specialist who felt it would be best if she could leave the broken plate in while the fusing was taking place, if it was not causing too much discomfort.After a few months the pain became too much and the specialist performed a third procedure (b)(6) 2018.During this procedure the broken plate was removed and another manufacturers plate was implanted.Patient is still recovering from the (b)(6) 2018 procedure but no longer is required to wear the boot.Patient still has some mild pain/discomfort but patient states that the surgeon feels this will resolve as the bones finish fusing.Part number for the screws explanted with the plate are unknown by reporter.

• Brand Name: LO-PRO STR MTP PLT,SHT,TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7947212
• Report Number: 1220246-2018-00702
• Device Sequence Number: 10995505
• Product Code: HRS
• UDI-Device Identifier: 00888867053182
• UDI-Public: 00888867053182
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: No Information
• Device Model Number: LO-PRO STR MTP PLT,SHT,TI
• Device Catalogue Number: AR-8944-P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/09/2018
• 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