MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 26MMCORT, STRL; BONE FIXATION PLATE

Model Number	LO-PRO SCRW,TI,3.0MMX 26MMCORT, STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2025
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
It was reported that during an osteotomy, the screwhead broke.The broken piece was left inside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-8933-26s batch 15288643 was received for evaluation, but only the screw head was received.Visual inspection revealed that the screw's head had detached from its body.Damage to the hex and signs of cross-threaded were also observed.Functional testing cannot be performed as the device was received broken/damaged.The received screw head was visually evaluated and measured according to drawing c0960 at revision 15; the received screw head matches the color specified on the drawing.After the measurement, some dimensions are out of specifications, most likely due to the damage to the head.The most likely cause of the reported failure is user error, including improper bone preparation and failure to seat the driver fully into the screw or to align the driver properly with the screw.Directions for use dfu-0125-eo arthrex low profile screws g.Precautions 4.Damage to the driver or screw may result from failure to seat the driver fully into the screw or to align the driver properly with the screw.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 26MMCORT, 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: 22297640
• Report Number: 1220246-2025-02589
• Device Sequence Number: 18283284
• Product Code: HRS
• UDI-Device Identifier: 00888867210578
• UDI-Public: (01)00888867210578(11)240716(17)290630(10)15288643
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K150456
• 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): 08/26/2025

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,TI,3.0MMX 26MMCORT, STRL
• Device Catalogue Number: AR-8933-26S
• Device Lot Number: 15288643
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown