MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 16MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 16MMCORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/30/2023
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.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.
Event or Problem Description
On 1/18/2024, an fda medwatch notification was received via email.A facility representative reported that an ar-2685dr-10 distal clavicle plate broke eight weeks post-operative.The patient underwent surgery on (b)(6) 2023 for an open reduction with internal fixation of the right comminuted mid-shift clavicle fracture.Eight weeks later, the patient returned to the clinic, experiencing painful pops in the shoulder.On (b)(6) 2023, the patient underwent revision surgery to remove the ar-2685dr-10 distal clavicle plate.The revision surgery was a revision open reduction and internal fixation of the right clavicle fracture with iliac bone graft and right clavicle hardware removal.No further information was reported.Additional information received on 1/23/2024: during the original procedure on (b)(6) 2023, an ar-2685dr-10 distal clavicle plate, an ar-8827l-20 low profile locking screw, (4) ar-8827l-18 low profile locking screw, (2) ar-8835-16 low profile screw, an ar-8835-18 low profile screw, (2) ar-8835l-18 low profile locking screw, and an ar-8835l-16 low profile locking screw were implanted.During the revision surgery on (b)(6) 2023, all the implants were successfully removed.The revision surgery was completed using an ar-2653cr clavicle fracture plate, (3) ar-8835-18 low profile screw, (3) ar-8835l-18 low profile locking screw, and an ar-8835l-16 low profile locking screw.Both procedures were completed at the same facility and by the same surgeon.
Additional Manufacturer Narrative
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 a patient-specific event.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Common Device Name: BONE FIXATION SCREW/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: 18725299
• Report Number: 1220246-2024-01011
• Device Sequence Number: 5805507
• Product Code: HWC
• UDI-Device Identifier: 00888867047297
• UDI-Public: 00888867047297
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Device Catalogue Number: AR-8835-16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 03/29/2025
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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