MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC EMAX 2 PLUS MOTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number EMAX2PLUS

Device Problems Unintended System Motion (1430); Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

It was reported that the motor device had an undetermined malfunction.It was further reported that the device was stopping and starting on its own.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: b5: upon subsequent follow-up with the customer, additional information was obtained.The reporter further clarified that the device was also sticking while being used together with the hand control device and cable device.Therefore, the hand control device and cable device has been included in this event and added as concomitant medical products.D10: concomitant med products and therapy dates: hand control device, cable device d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.B5: upon subsequent follow-up with the customer, additional information was obtained.According to the reporter, the scrub technician stated that when the surgeon moved their hand, the handpiece seemed to short out.It kept turning on and off by itself.It was reported that the event occurred during surgery.There was less than a thirty-minute delay to obtain a replacement drill device.It was reported that there was no smoke or burning smell.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.During repair, an evaluation was performed, and it was determined that the reported condition of the device stopping and starting on its own was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the pin was pushed back in the connector, the flex circuit was damaged, and the component was also damaged.It was further determined that the device failed pretest for no short circuit between phases and connector body (42) assessment.The assignable root cause was determined to be traced to user, which is user error.11.Corrected data correction: device availability: d9: the device availability date was incorrect in the initial report.The date has been updated from 7/9/2021 to 7/8/2021.

• Brand Name: EMAX 2 PLUS MOTOR
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12122754
• MDR Text Key: 260087389
• Report Number: 1045834-2021-01163
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00845384002055
• UDI-Public: 00845384002055
• Combination Product (y/n): N
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMAX2PLUS
• Device Catalogue Number: EMAX2PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1