MAUDE Adverse Event Report: ARTHREX, INC. OSFERION OSTEO WEDGE, 12 MM X 35 MM; BONE FIXATION PLATE

Model Number	OSFERION OSTEO WEDGE, 12 MM X 35 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
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 (2) ar-13380-42 cortical screws were found broken during a post-operative follow-up.The procedure was a high tibial osteotomy.The patient did not have any significant complaints and did not recall an event or injury to have occurred.A collapse was noticed in the patient's osteotomy site.The implants are still in the patient, and revision surgery has not happened yet.Additional information received on 6/8/2023: the original procedure occurred on (b)(6)2023, and revision surgery occurred on (b)(6)2023.Additional information received on 6/16/2023: during the revision surgery, an ar-13200t-12.5 tibial opening wedge osteotomy plate, two ar-13280-45 cancellous screw, and three ar-13370-3 osferion osteotomy wedge were explanted along with the two broken ar-13380-42 cortical screws.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 x-ray and images submitted for evaluation, arthrex was able to conclude a most likely cause for the complaint allegation.The most likely cause for the reported failure can be attributed to a patient-specific event.
Additional Manufacturer Narrative
Corrected info: g4.

• Brand Name: OSFERION OSTEO WEDGE, 12 MM X 35 MM
• 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: 17246975
• Report Number: 1220246-2023-07022
• Device Sequence Number: 4871798
• Product Code: HRS
• UDI-Device Identifier: 00888867011564
• UDI-Public: 00888867011564
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K080065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2026

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: OSFERION OSTEO WEDGE, 12 MM X 35 MM
• Device Catalogue Number: AR-13370-3
• 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: 02/17/2025; Not provided
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 02/24/2025; 03/17/2026
• 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