MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC HYBRID HAND CONTROL, EMAX2; MOTOR, DRILL, ELECTRIC - HAND CONTROL

Catalog Number	EMAX2-HC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device serial/lot number is unknown; therefore, udi: (b)(4).Device manufacture date was unknown.The device serial or lot number was unknown.Concomitant med products and therapy dates: motor device, cutter device and attachment device and handset device, (b)(6) 2019.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
This is report 1 of 4 for the same event.It was reported that during an anterior cervical discectomy surgical procedure (under microscope), it was observed that the motor device, while being used with a handset device, burr device and an attachment device, was continually overheating.It was reported that due to limited drill availability at the time, the user persevered reducing the length of the duty cycle (time of continued use) to allow the drill to cool in between uses.It was further reported that during bone smoothing at the posterior and cervical end plate and near the spinal cord, the user observed a combination of dark fluid and what appeared to be darker metal filings which sprayed into the disc space.It was at this point that the user stopped drilling and proceeded to liberally irrigate the area in order to cool the liquid that may have been hot in order to prevent damage to the cord.It was reported that after several minutes the user and assistant were able to suck up the fluid along with any foreign debris.After careful inspection of the surgical site, the surgeon continued the discectomy and fusion without the use of the drill.It was reported that there was a 15-20 minute delay in the surgical procedure.It was reported that the procedure was completed without the use of the drill.There was patient involvement.There were no reports of injuries or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: HYBRID HAND CONTROL, EMAX2
• Common Device Name: MOTOR, DRILL, ELECTRIC - HAND CONTROL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9412143
• Report Number: 1045834-2019-54938
• Device Sequence Number: 4202651
• Product Code: HBC
• UDI-Device Identifier: 00845384002031
• UDI-Public: 00845384002031
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EMAX2-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 12/04/2019
• 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