MAUDE Adverse Event Report: MISONIX INC BONESCALPEL, 25MM. BLUNT BLADE; ULTRASONIC SURGICAL SYSTEM

Model Number	MXB-25
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was for a broken bonescalpel, 25mm.Blunt mxb-25, lot number not reported.The blade that is the subject of this event was not returned to misonix to date.Patient details were not reported.Surgical procedure details were reported as a mandibular osteotomy.Customer stated problem as "the tip of a thin bonescalpel blade broke while we were using it in the operating room on (b)(6) 2018.It was in heavy use at the time - the breakage occurred during our 4th mandibular osteotomy.We were able to find about ½ of the tip in the wound, but could not find the other half.On postop x-ray, we think we see it as a small metallic fragment.We informed the patient and we do not feel there will be any long-term consequence." a serious injury to the patient or user was determined as unknown by the user facility.Medical intervention required to preclude serious injury was not reported.Delay in treatment was reported.There was no extended stay of the patient reported.There was no medical intervention required to prevent permanent impairment of body structure damage to body structure.Mxb-25 is a sterile procedure kit containing multiple component parts including (b)(4) blade - 25mm.The trend analysis indicates 2 complaints in total have been reported (including the subject event) were returned from november 16, 2017 through november 16, 2018.Misonix has sold (b)(4) mxb-25 from november 1, 2017 to october 31, 2018.The blade failure rate, based on the area of opportunity defined as the number of mxb-25 shipped is (b)(4); the other compliant resulted in the removal of the fragment.No adverse trends are noted.The blade failure rate, and corresponding likelihood of harm for a broken blade is still below the rate estimated in the original risk assessment.Therefore, there is no change in risk probability, residual risk, or risk-benefit ratio.Since the blade subject of this event was not returned, inspection and testing cannot be performed.Blades can break based on the surgical procedure, surgical technique, and interactions with other associated medical devices used during the surgical procedure.The ifu contains notes, warnings and cautions that will be discussed below.Procedures performed using the bonescalpel ultrasonic system involves a number of associated metal medical devices.Contact of the ultrasonic surgical probe with other metal devices will cause premature fracture.Our ifu contains the following note: note 4.3: contact of the ultrasonic tip or exposed extension with metal, surgical instruments or other objects during ultrasound use must be avoided.Such contact can damage the ultrasonic components very easily and may result in compromised performance, including failure.Discard any extensions or tips that show signs of damages like gouges, nicks or fractures.External aspiration may be used but it is not but it is recommended that a plastic suction tip should be used when in proximity of the probe tip.Excessive or extreme conditions of use can cause blades to break.Our ifu contains the following warnings: warning 4.3: ultrasonic tips can break under excessive use in extreme conditions, e.G.When cutting for extended duration in tight cavities with limited lateral motion.The tip could break into two or more fragments with the main fragment remaining attached to the handpiece.All fragments must be retrieved immediately from the surgical site.The fragments should be checked to ensure that no further pieces are missing.It is possible that a fragment is propelled outside of the surgical cavity.Diagnostic imaging, such as x-ray, must be used if a fragment cannot be found to confirm that the broken piece is outside of the surgical cavity.In addition, during surgery, other metal medical devices are used.Contact of the ultrasonic tip with other metal devices during surgery can damage the ultrasonic tip and cause fracture.Warning 4.4: breakage of ultrasonic tips will result in sharp edges that can be harmful to soft tissue even without activation of ultrasound.Tips can bend or deform before they actually break.Tips showing signs of deformation or cracking should be replaced immediately since tip breakage is otherwise imminent.Do not bend or twist the ultrasonic tips since it reduces the structural integrity and can result in tip breakage during use.Dispose of deformed or broken tips immediately in a sharps container.The product ifu contains the following cautions and warning(s) designed to assure delay in treatment in case of system malfunction does not result in a significant delay in treatment: caution 7.7: the system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction.Warning 1.2: the bonescalpel system is intended to be used in various types of invasive, surgical procedures.There may be indirect danger to the patient should the device fail during the procedure.It is recommended that the facility follows its back-up equipment protocols.Discussion: the predominant failure mode of ultrasonic attachments (e.G.Blades) is a partial or complete fracture; they do not shatter creating multiple fragments that would be difficult to locate or remove.The complaint reported that the blade broke, verifying the predominant failure mode as a fracture.Because the surgical procedure is performed under the surgeon's direct visualization "and", the instrument failure can be promptly identified.Furthermore, the system is "design" to emit "limit" alarms when the blades fracture, further communicating to the user that something abnormal has occurred.When the blade "factures", triggering the "limit" alarm, the device stops energizing the handpiece to which the blade is attached.All surgical suites have access to x-ray equipment and in the event of a fracture, would be able to quickly identify and locate any fragments using such equipment.The fractured piece could therefore be found quickly and easily without any delay in the surgical procedure.The blades are shipped as sterile components; therefore, the blade can be replaced with a new one, without any substantial delay in the surgical procedure.In the event that the bonescalpel could not be used to complete the procedure; surgical suites have access to alternative technologies that can be used without significant delay in treatment.Conclusion: this is the first incident of a blade break where a portion of a broken blade is assumed to have been left in the patient.The reporter has not definitively concluded this fact but rather "thinks" this is the case.The health care institution informed the patient that there will be no long term consequences.The blade is made of surgical grade titanium ((b)(4)), and used for other surgical implant applications.There are only two complaints for broken blades.The failure rate for broken blades is (b)(4) based on the total number of mxb-25 blades sold from november 1, 2017 to october 31, 2018.This rate is below the estimated risk probability and with the risk-benefit ratio of our original risk assessment.Warnings published in our ifu indicate blade breakage can be related to surgical technique.Misonix inc.Will follow-up with the health care institution and health care professionals reporting this event for in-service training.
Event or Problem Description
Customer stated problem as "the tip of a thin bonescalpel blade broke while we were using it in the operating room on (b)(6) 2018.It was in heavy use at the time - the breakage occurred during our 4th mandibular osteotomy.We were able to find about ½ of the tip in the wound, but could not find the other half.On postop x-ray, we think we see it as a small metallic fragment.We informed the patient and we do not feel there will be any long-term consequence.".

• Brand Name: BONESCALPEL, 25MM. BLUNT BLADE
• Common Device Name: ULTRASONIC SURGICAL SYSTEM
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11735
• MDR Report Key: 8161337
• Report Number: 2435119-2018-00015
• Device Sequence Number: 13984898
• Product Code: LFL
• UDI-Device Identifier: 00841626101197
• UDI-Public: 00841626101197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/13/2018
• 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: Required Intervention