MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS DUO+PUMP/SHAVER UNIT; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Catalog Number 284580

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during service evaluation, it was determined that the pump/shaver device failed electrical safety test.There was no procedure nor patient involvement reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received at the service center and evaluated.There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation.This complaint can be confirmed.It was found during evaluation that the both the covers of the device damaged.Further, unit was not calibrated correctly.The irreparable cover was replaced, unit calibrated newly, defective material exchanged, a mechanical upgrade was performed, pressure mechanism re-adjusted, pneumatic circuit checked, 8-hour endurance test carried out and the device was cleaned, repaired, tested and found to be fully functional.The identified failures clearly are a result of user mishandling of the device or a probable fall during transport or storage.User error would have resulted in the incorrect calibration of the device.There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: FMS DUO+PUMP/SHAVER UNIT
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11100922
• MDR Text Key: 225084387
• Report Number: 1221934-2020-04171
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1