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

Catalog Number EMAX2PLUS

Device Problems Detachment of Device or Device Component (2907); Fail-Safe Problem (2936)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that the motor device cord came apart where it connects to the drill.During an in-house engineering evaluation, it was determined that the device had cord damage and ran in the locked position - power broken.It was also found that the device failed pre-test for visual and safety.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 the surgical procedure, or if a spare device was available for use.It was not reported if there were any 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.

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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to user error.Udi:(b)(4).

• 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
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 19030812
• MDR Text Key: 339214164
• Report Number: 1045834-2024-00343
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 84538400205
• UDI-Public: 84538400205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EMAX2PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Date Manufacturer Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1