MAUDE Adverse Event Report: ARTHREX, INC. OSTEOTOME, ANGLED UP, 5.5 MM; ARTHROSCOPIC ACCESSORIES

Model Number	OSTEOTOME, ANGLED UP, 5.5 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2024
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 04/11/2024, it was reported by a sales representative via (b)(4) that an ar-8650-08 osteotome tip broke off.This occurred during a case when it was barely tapped the tip snapped off.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was determined that the distal end of the shaft of the osteotome, angled up, 5.5 mm, is broken.It was observed that the base of the handle was peeled.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Manufacturing date 2015.

• Brand Name: OSTEOTOME, ANGLED UP, 5.5 MM
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 19260737
• Report Number: 1220246-2024-02897
• Device Sequence Number: 16786516
• Product Code: NBH
• UDI-Device Identifier: 00888867044227
• UDI-Public: 00888867044227
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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, ANGLED UP, 5.5 MM
• Device Catalogue Number: AR-8650-08
• Device Lot Number: 031545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown