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

Catalog Number EMAX2PLUS

Device Problems Mechanical Problem (1384); Fail-Safe Did Not Operate (4046)

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

Event Date 12/21/2023

Event Type  malfunction  

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: e1: the reporter¿s phone number and complete facility address were not provided.Device evaluation: 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 from japan that during an craniotomy surgical procedure, it was discovered that the compact speed reducer device, which was connected to perforator device, continued to rotate while the foot pedal was depressed.It was further reported that the release mechanism of the compact speed reducer device did not work and the dura mater was perforated.The gears of inner and outer blades were released and spinning idle.It was not reported if there were any delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.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: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device ran in locked position.It was further determined that the device had corrosion/rusting/pitting, and foreign substance/debris/cleaning/sterilization.It was further determined that the device¿s stainless teel wire tether was damaged/came off.It was further determined that the device failed pretest for visual assessment and safety assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure from wear.

• 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 ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18550809
• MDR Text Key: 333378637
• Report Number: 1045834-2024-00074
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00845384002055
• UDI-Public: 00845384002055
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1