MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 18MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 18MMCORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/27/2023, an fda medwatch notification was received via email.A facility representative reported that an ar-8835-18 low profile screw head broke off during insertion.The body of the screw was left implanted and the head was removed.This was discovered during an orif of the right clavicle procedure on 9/13/2023.No further information was reported.
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 descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is misuse of the product, caused by the surgeon using excessive force and damaging the head of the screw.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 18MMCORT
• 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: emily shafer ; 8009337001
• MDR Report Key: 18175227
• Report Number: 1220246-2023-08826
• Device Sequence Number: 18055649
• Product Code: HWC
• UDI-Device Identifier: 00888867047303
• UDI-Public: 00888867047303
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: LO-PRO SCRW TM,SS 3.5X 18MMCORT
• Device Catalogue Number: AR-8835-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown