MAUDE Adverse Event Report: ARTHREX, INC. OSTEOTOME, ANKLE ARTHRO SCOPY, CURVED; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	OSTEOTOME, ANKLE ARTHRO SCOPY, CURVED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
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
On (b)(6) 2022, it was reported by a sales representative via sems that an ar-8655-09 osteotome, ankle arthroscopy, curved broke during the bone preparation of the ankle.The surgeon noticed the osteotome was already weakened.This occurred during an ankle fusion procedure on (b)(6) 2022, the tip of the blade broke in the middle of the arthroscopy, the broken piece was fully retrieved and the procedure was completed, no second surgery was necessary.The event occurred during the initial/first time use of the device.This was discovered during use with no impact to the patient.
Additional Manufacturer Narrative
Complaint confirmed.The complaint is confirmed based on customer provided photo, which displays the osteotome, ankle arthroscopy, curved is broken at the distal end of the shaft.However, without return of the device and broken piece for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: OSTEOTOME, ANKLE ARTHRO SCOPY, CURVED
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 15093216
• Report Number: 1220246-2022-05279
• Device Sequence Number: 19827966
• Product Code: MDM
• UDI-Device Identifier: 00888867044319
• UDI-Public: 00888867044319
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: OSTEOTOME, ANKLE ARTHRO SCOPY, CURVED
• Device Catalogue Number: AR-8655-09
• Device Lot Number: 1392125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 02/13/2023
• Date Device Manufactured: 07/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown