MAUDE Adverse Event Report: MISONIX INC. BONESCALPEL ULTRASONIC SURGICAL SYSTEM; ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Model Number	MXB-MIS-20LCRS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the returned product, mxb-mis-20lcrs, lot 78343, indicated that the blade fractured into two pieces across the distal quarter of the blade.Dimensions were within specification and no surface anomalies or machining defects were observed that could cause or contribute to a fracture.It is unclear from the report whether irrigant was at the tip at the onset of vibratory activation.The instructions for use manual, bcm-um, provides adequate instructions for performing set up prior to use.Section 7.4 of the manual instructs the user to check that the ultrasound is in standby mode during priming.This prevents the tip from being activated during priming when no irrigant is present.We cannot determine a definitive root cause.A potential root cause of the fracture is that the tip was activated (vibration was turned on) without irrigant present.Irrigation dampens (disperses) energy in the vibrating blade reducing dynamic stress that can cause fatigue.Running a blade without the benefit of damping provided by irrigation can result in exceeding the fatigue limit of the blade and resulting in a break or fracture.
Event or Problem Description
Stöckli medical ag reported the following: "blade was mounted on the handpiece and the or staff started with the irrigation.The blade broke during the first irrigation.Was done beside the or field.No contact to patient." in a follow-up call with the clinic, a misonix sales representative stated that the nurse confirmed that no one was injured.

• Brand Name: BONESCALPEL ULTRASONIC SURGICAL SYSTEM
• Common Device Name: ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Manufacturer (Section D): MISONIX INC.; 1938 new highway; farmingdale NY 11735
• MDR Report Key: 12242118
• Report Number: 2435119-2021-00018
• Device Sequence Number: 1494122
• Product Code: LFL
• UDI-Device Identifier: 00841626101487
• UDI-Public: 00841626101487
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K070313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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 Model Number: MXB-MIS-20LCRS
• Device Lot Number: 78343
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other