MAUDE Adverse Event Report: ARTHREX, INC. PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL; PLATE, FIXATION, BONE

Model Number	PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the device broke after implantation.The device was implanted on the (b)(6) 2021 and on the (b)(6) 2022 the device was explanted.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection it was noted that the device had broken in half between the first and second holes from the t end of the device.The thickness was measured on each piece of the device and was found to meet the specifications of drawing ar-13100t.The cause of this remains undetermined.

• Brand Name: PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
• Common Device Name: PLATE, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13995012
• Report Number: 1220246-2022-04692
• Device Sequence Number: 19941531
• Product Code: HRS
• UDI-Device Identifier: 00888867007703
• UDI-Public: 00888867007703
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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 Expiration Date: 03/31/2026
• Device Model Number: PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
• Device Catalogue Number: AR-13100T-17.5
• Device Lot Number: 13102248
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown