MAUDE Adverse Event Report: ARTHREX, INC. MAXFORCE MTP PLATE, STD, 0°-0°, RIGHT; BONE FIXATION PLATE

Model Number	MAXFORCE MTP PLATE, STD, 0°-0°, RIGHT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 4/15/2024, it was reported by a healthcare professional/surgeon via phone that an unknown locking screw with an unknown lot number had an issue during a first mtp fusion procedure on (b)(6) 2024.When the surgeon was using the first mtp fusion plate, a locking screw was put in and had to be replaced because it was too long.Another shorter locking screw was put in, and a curly piece of metal debris, like a sharp wire, smaller than an eyelash, separated from the screw and broke off inside the patient, which was initially not noticed.When washing out the wound, the metal piece stabbed the surgeon's thumb.When withdrawing her hand, the metal piece was stuck in her thumb, went through two gloves, and pierced the surgeon's skin.The surgeon washed and disinfected her hand and then proceeded to complete the procedure successfully with no patient harm.There was a case delay of 45 seconds, and no additional anesthesia was administered.This occurred during use with no patient harm.Additional information has been requested.On 4/16/2024, the sales representative provided the following additional information via phone: an ar-8944s-0r maxforce mtp plate and an ar-9944s-0r val kreulock screw with unknown lot numbers were used in the case.The surgeon was not satisfied with how the plate was seated.She removed the locking screw against the recommendation of the sales representative at a variable angle, which caused a metal shard to be produced, which was caused by damage to the threading.The metal shard was discarded.He was not aware of any prior occurrences with those devices; it could have been an issue with different product part numbers, but he was not aware of or could recollect any prior case issues.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: MAXFORCE MTP PLATE, STD, 0°-0°, RIGHT
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19316253
• Report Number: 1220246-2024-03281
• Device Sequence Number: 6320411
• Product Code: HRS
• UDI-Device Identifier: 00888867345720
• UDI-Public: 00888867345720
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K201235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 Model Number: MAXFORCE MTP PLATE, STD, 0°-0°, RIGHT
• Device Catalogue Number: AR-9944S-0R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown