MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,STER. 4.5X32MMCANN PT THD.; BONE FIXATION PLATE

Model Number	LO-PRO SCRW,STER. 4.5X32MMCANN PT THD.
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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 a latarjet surgery the screw broke inside the bone.All parts were retrieved.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: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-8945-32pts, batch/serial (b)(6), was received for investigation.Functional testing could not be performed due to the damage to the device.Upon visual evaluation, the screw had broken off at the distal end.No fragments were returned for evaluation.The most likely cause can be attributed to misuse due to misaligned insertion or prying/leveraging the screw during insertion.

• Brand Name: LO-PRO SCRW,STER. 4.5X32MMCANN 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: 21470377
• Report Number: 1220246-2025-00682
• Device Sequence Number: 18321254
• Product Code: HRS
• UDI-Device Identifier: 00888867053533
• UDI-Public: (01)00888867053533(11)241125(17)291031(10)15353139
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/29/2025

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. 4.5X32MMCANN PT THD.
• Device Catalogue Number: AR-8945-32PTS
• Device Lot Number: 15353139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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