MAUDE Adverse Event Report: THE ANSPACH EFFORT LLC EMAX 2 PLUS MOTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number EMAX2PLUS

Device Problems Material Frayed (1262); Vibration (1674)

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

Event Date 01/01/2023

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 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 traced to component failure due to normal wear.(b)(4).

Event Description

It was reported from japan that during service and evaluation, it was determined that the motor device cord was damaged, loose, made excessive noise, the bearing was worn and was vibrating.It was also noted that the hose was cracked, the housing pin and set screw were loose, air cooling ng due to hose crack, abnormal noise and vibration.It was further determined that the device failed pretests for visual assessments, loctite assessments, noise assessment and air pump assessment.It was noted in the service order that the device had a damaged hose.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2023.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: EMAX 2 PLUS MOTOR
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): THE ANSPACH EFFORT 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: 18583236
• MDR Text Key: 333931408
• Report Number: 1045834-2024-00096
• 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
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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: 12/28/2023
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1