MAUDE Adverse Event Report: MISONIX INC. MISONIX BONESCALPEL HANDPIECE

Model Number	BCM-HP
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation: the device history record for the subject handpiece, and all subassembly history records, was reviewed.The device history records indicated all assembly procedures were completed with no deviations and all inspection and tests results conformed to specifications.Misonix has issued a returned materials authorization (rma) and requested the health care institution to return subject handpiece for evaluation.The device has not been returned to misonix as of the date of this report.Therefore, further investigation to determine potential root cause cannot be conducted as of the date of this report.Misonix cannot determine if a serious injury occurred because the degree of the burn was not identified.The report does not indicate medical intervention was necessary to prevent serious injury.Misonix has contacted the health care institution for additional information.Conclusion: misonix will file a follow-up report once the subject handpiece is returned for evaluation.
Event or Problem Description
(b)(6) representative, (b)(6), provided a translated incident report to misonix on 03/25/2021."power on of the misonix bonescalpel hand piece, after having purged the irrigation tubing, the handpiece started to heat up, burning the surgeon who was holding it, forcing him to put down the hand piece which started to melt and release smoke.".

• Brand Name: MISONIX BONESCALPEL HANDPIECE
• Common Device Name: MISONIX BONESCALPEL HANDPIECE
• Manufacturer (Section D): MISONIX INC.; 1938 new highway; farmingdale NY 11735
• MDR Report Key: 11720146
• Report Number: 2435119-2021-00001
• Device Sequence Number: 3832902
• Product Code: LFL
• UDI-Device Identifier: 00841626100688
• UDI-Public: 00841626100688
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: BCM-HP
• Device Catalogue Number: BCM-HP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2435119-2021-001
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other