MAUDE Adverse Event Report: MISONIX INC BONESCALPEL, 20MM, LONG CURVED RIGID BLUNT BLADE; ULTRASONIC SURGICAL SYSTEM

Model Number MXB-MIS-20LCRS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Misonix received (b)(4) for a malfunction of mxb-mis-20lcrs, lot# 759963, reporting "upon priming the irrigation tubing, tip shot out sparks and blew off forcefully.Thankfully, no one was injured or in the way of the tip expulsion." on (b)(6) 2018.No details of the circumstances of use were provided.Therefore, we are unable to verify the device was used consistent with the bonescalpel ultrasonic surgical system instructions for use and indications for use.No patient details were provided.No details of the clinical history or surgical procedure were provided.Therefore, we are unable to determine if the device was used within the labeled indications for use or whether there was relevant clinical history.A serious injury to the patient or user was not reported.Medical intervention required to preclude serious injury was not reported.Delay in treatment was not reported.Dhr review: a review of the dhr for bonescalpel, 20 mm, long curved rigid blunt blade, bearing lot # 759963 indicates the lot was received on may 12, 2017 and accepted without nonconformance.It is noted that mxb-mis-20lcrs is a sterile kit containing multiple component parts.The blade contained in the mxb-mis-20lcrs sterile kit is e4006abc20 blade - 20 mm.Incoming inspection records indicate that mxb-mis-20lcrs lot#759963 contained e4006abc20 lot# 106670.Review of incoming inspection records for the e4006abc20 indicate that the manufacturer's lots were accepted without nonconformance.Misonix has sold (b)(4) mxb-mis-20lcrs from january 23, 2017 through january 23, 2018.Trend analysis: two (2) bonescalpel, 20 mm, long curved rigid blunt blade, mxb-mis-20lcrs were returned to misonix from january 23, 2017 through january 23, 2018 where the service/engineering evaluation found a broken blade problem.Review of the specifics surrounding the details does not involve any other reports of malfunction.The return rate for this problem during the time period indicated above is 0.08%.There are no other mxb-mis-20lcrs complaint returns for the reported lot# 759963.This frequency is below the estimated frequency in our risk management file and is considered remote.There is no change in the estimated risk probability number or risk/benefit in our risk management file.Engineering evaluation: the devices were received at misonix on january 30, 2018 under (b)(4) and forwarded to engineering for evaluation.The complaint states that the tip sparked and fractured while priming the irrigation line.User manual section 7.4 instructs to prime the irrigation line prior to use, by first verifying that ultrasound is in standby mode, and then setting flowrate to 10, and then depressing the footswitch (caution 7.7 reinforces the importance of this).Therefore, since the event occurred during priming the irrigation line in accordance with the instructions for use, the event occurred prior to patient use and the event was a detectable by the user.In addition, if the tip fractured and sparked, ultrasound must have been active during this process, which indicates that the event was misuse because there was a deviation from section 7.4 of the instructions for use manual.When ultrasonic tips vibrate without the stabilizing effect of irrigant, especially for extended periods, tip instability can occur which can lead to failure due to excessive stresses induced by unintended transverse motion of the tip.Inspection of the blade and horn did not reveal any manufacturing or metallurgical defects under visual magnification (approx.4x).The blade did not exhibit discoloration consistent with use in bone.The returned molded housing and sheath did not appear to be damaged or faulty upon cursory visualization.The predominant failure mode for ultrasonic bonescalpel, 20 mm, long curved rigid blunt blade, that break during use is a partial or complete fracture.They typically do not shatter or create multiple irretrievable fragments that would difficult to locate or remove.The system is design to emit a visual and audible "mechanical limit" alarm when a tips fracture, communicating to the user the fault condition.When the tip fractures, triggering the "mechanical limit" alarm, the device stops energizing the handpiece to which the tip is attached.In the event that the bonescalpel couldn't be used to complete the procedure, surgical suites have access to alternative technologies that can be used to complete the surgical procedure without significant delay in treatment.The product ifu (bcm-um, revision p) contains the following warning(s): 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.Caution 7.7: prime the irrigation tubing prior to use.At all times ensure that the irrigant flows towards the handpiece when footswitch is depressed.If no irrigant is flowing, cease use until flow is restored.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.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.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.Conclusion: based on the information provided, there does not appear to be a malfunction of the device that caused or contributed to the event.There is no definitive root cause.A potential root cause is misuse due to a deviation from the instructions for use manual.There was no serious injury or delay in treatment reported.This event is being reported because, in the opinion of the reporter, there was a potential for injury.From a risk management perspective, there is no risk to the patient because the event occurred prior to use.The potential for serious injury to the user is remote.

Event Description

Customer stated problem was "upon priming the irrigation tubing, tip shot out sparks and blew off forcefully.Thankfully, no one was injured or in the way of the tip expulsion.".

• Brand Name: BONESCALPEL, 20MM, LONG CURVED RIGID BLUNT BLADE
• Type of Device: ULTRASONIC SURGICAL SYSTEM
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11735
• Manufacturer (Section G): MISONIX INC; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: anne bailey ; 1938 new highway; farmingdale, NY 11735 ; 6316949555
• MDR Report Key: 7290541
• MDR Text Key: 101018866
• Report Number: 2435119-2018-00003
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00841626101197
• UDI-Public: 00841626101197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physicist
• Device Expiration Date: 04/15/2019
• Device Model Number: MXB-MIS-20LCRS
• Device Lot Number: 759963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1