MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 24MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW,TI,3.5MMX 24MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/19/2024, it was reported by a sales representative via email that an alpha plate broke postoperatively.The patient was picking up the cat and felt a break.X-rays confirm the plate broke through the oblong hole in the first bend of the plate.No additional information was provided.Additional information received on 2/6/2025: on (b)(6) 2024, the patient underwent revision surgery due to the left alpha plate breaking and causing the reinforced straight plate to dislodge.A 3024-011 left alpha plate, an ar-8935-24 low profile screw, titanium, non-locking, an 8110-026 cortical bone screw, an 8110-024 cortical bone screw, two 8110-028 cortical bone screw, two 8124-036 cancellous locking screw, two 8124-044 cancellous locking screw, an 8124-032 cancellous locking screw, an 8124-048 cancellous locking screw, an 8124-046 cancellous locking screw, three 8114-026 double lead lock cortical screw, an 8124-042 cancellous locking screw, an 8124-038 cancellous locking screw, and an 8124-030 cancellous locking screw, an ar-18827p-16 20 hole reinforced straight plate, an ar-18827-30 cortical screw, ar-18827-18 cortical screw, ar-18827v-18, an ar-18827v-16 val screw, an ar-18827v-22 val screw, two ar-18827v-20 val screw an ar-18827v-10 val screw, and an abs-2010-10 allosync pure were explanted during the revision surgery.During the removal of the screws, two broke off.At this time, it is unknown what were the part numbers of the broken screws and if they were fully removed from the patient.The revision surgery was completed using products from another manufacturer.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation that an alpha plate broke postoperatively is confirmed.However, there is no problem found with the received screw.Based on the x-rays submitted from the field of the low profile screw, titanium, non-locking, 3.5 x 24 mm, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.Per dfu-0139-eo, revision 1: "postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight-bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.".

• Brand Name: LO-PRO SCRW,TI,3.5MMX 24MM
• 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: jared engle ; 8009337001
• MDR Report Key: 21503558
• Report Number: 1220246-2025-00754
• Device Sequence Number: 8007246
• Product Code: HWC
• UDI-Device Identifier: 00888867050501
• UDI-Public: (01)00888867050501(11)220908(10)14999900
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.5MMX 24MM
• Device Catalogue Number: AR-8935-24
• Device Lot Number: 14999900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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