MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CORTICAL; BONE FIXATION PLATE

Model Number	SCREW, CORTICAL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/7/2023, it was reported by a sales representative via email that an ar-13280-35 and ar-13280-50 cancellous screw broke post-operative.This was discovered during a post-operation follow-up x-ray on (b)(6) 2023.The patient has complained of a sensation of instability but does not report a specific event or time frame in which the instability started.The implants are still in the patient, and revision surgery has not occurred yet.Additional information received on 6/8/2023: the original procedure occurred on (b)(6) 2022, and revision surgery occurred on (b)(6) 2023.Additional information received on 6/16/2023: during the revision surgery, an abs-3016 synthetic bone filler, an ar-13200st-17.5 tibial a/p sloped osteotomy plate, three ar-13370-4 osferion osteotomy wedge, an ar-13380-40 cortical screw, and an ar-13380-46 cortical screw were explanted along with the broken ar-13280-35 and ar-13280-50 cancellous screw.Both surgeries were performed at the same facility and by the same surgeon.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed.Based on the image submitted for evaluation from the field, it was noted that the distal tip of the screw was broken.Consequently, 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.

• Brand Name: SCREW, CORTICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 17248047
• Report Number: 1220246-2023-07037
• Device Sequence Number: 4872291
• Product Code: HRS
• UDI-Device Identifier: 00888867011588
• UDI-Public: 00888867011588
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCREW, CORTICAL
• Device Catalogue Number: AR-13380-46
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown