MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
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
It was reported that during a metatarsophalangeal joints (mtp joints) surgery of the first metatarsal joint when filling the oblong hole on the standard left contoured plate the 3mm x 18mm cortical screw head snapped and the screw was now not retrievable from hole without head to hold to drive out.The surgeon reported that there was no resistance felt or anything unusual prior to driving screw into hole and all correct drill/ guides were used as per optech and instrumentation system.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.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 misaligned insertion and/or excessive force being used during insertion of the screw.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL
• 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: 18352112
• Report Number: 1220246-2023-09472
• Device Sequence Number: 18249105
• Product Code: HWC
• UDI-Device Identifier: 00888867210530
• UDI-Public: 00888867210530
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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 Expiration Date: 05/31/2025
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL
• Device Catalogue Number: AR-8933-18S
• Device Lot Number: 11166123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2020
• 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
• Patient Sex: Unknown