MAUDE Adverse Event Report: ARTHREX, INC. DIST HUM FRAC PLT,EA,TI,LFT,11H,STRL; BONE FIXATION PLATE

Model Number	DIST HUM FRAC PLT,EA,TI,LFT,11H,STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/29/2025, it was reported by a sales representative via phone that an ar-8935-24 screw broke while going into a ar-7654el-11s.This occurred during use in a case with no patient effect.The case was completed by leaving the broken hardware in and using other screw holes.No delay to the case.
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 user error of the device due to over-torquing the screw when inserting into the plate and/or hard bone.

• Brand Name: DIST HUM FRAC PLT,EA,TI,LFT,11H,STRL
• 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: 22795132
• Report Number: 1220246-2025-03479
• Device Sequence Number: 12963933
• Product Code: HRS
• UDI-Device Identifier: 00888867435483
• UDI-Public: (01)00888867435483(11)250501(17)300430(10)15429334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K242079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Model Number: DIST HUM FRAC PLT,EA,TI,LFT,11H,STRL
• Device Catalogue Number: AR-7654EL-11S
• Device Lot Number: 15429334
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown