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

Catalog Number	EMAX2-HC
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined.A visual and functional assessment was performed on the device which found that the hand control will not slide into lock position.During repair the it was observed that the hand control was missing rear o-ring and front o-ring is worn and damaged/cut.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
This is report 1 of 2 for the same event: it was reported that during an unspecified cervical surgical procedure, it was observed that the motor device could not secure attachment devices.It was further reported that the hand control device would not go into the lock position while in use with the motor device.As a result, there was a twenty-nine minute delay to the surgical procedure.A spare device was available for use, and the surgical procedure was successfully completed with no further issues.There was patient involvement.There were no injuries, medical intervention 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
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• MDR Report Key: 7101385
• Report Number: 1045834-2017-50141
• Device Sequence Number: 13927063
• Product Code: HBC
• UDI-Device Identifier: 00845384002031
• UDI-Public: (01)00845384002031(11)161201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EMAX2-HC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1