MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,STER. 4.5X45MMCANN PT THD.; BONE FIXATION PLATE

Model Number	LO-PRO SCRW,STER. 4.5X45MMCANN PT THD.
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic surgery the thread of the screw was damaged.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-8945-45pts with serial/batch number (b)(6) was received for evaluation.Functional testing was not performed due to damage to the device threads and head.A visual inspection revealed nicks and deformation on the threads and head.The reported failure is caused by user error, specifically applying excessive force during use and misaligning the insertion.Directions for use (dfu) 0125 arthrex low profile screws: g.Precautions: 3.Use the appropriately sized drill bit for the screw.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.Use solid driver as opposed to a cannulated driver for screw removal.

• Brand Name: LO-PRO SCRW,STER. 4.5X45MMCANN PT THD.
• 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: 21409656
• Report Number: 1220246-2025-00528
• Device Sequence Number: 9382189
• Product Code: HRS
• UDI-Device Identifier: 00888867053779
• UDI-Public: (01)00888867053779(11)230927(17)280831(10)15146856
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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,STER. 4.5X45MMCANN PT THD.
• Device Catalogue Number: AR-8945-45PTS
• Device Lot Number: 15146856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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