MAUDE Adverse Event Report: DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Model Number 284580

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

It was reported by the affiliate via phone that during an unknown procedure the 4580 fms duo+ pump/shaver combo -ns didn't passed the electrical safety test.The procedure was completed using a replacement.No patient consequence and no surgical delay was reported.No additional information was provided.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the unit duo + pump/shaver combo, didn't pass electrical safety.Per service manual operational and diagnostic, the reported failure was not confirmed.  during evaluation, the unit presented defective cpu board and was replaced the unit was calibrated newly, functional test performed, electrical safety test was completed, the motor sticks and is rusty, the cable resistance is out of tolerance, mechanical upgrade was performed.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The possible root cause for the reported failure was thus identified as faulty parts-components.  a manufacturing record evaluation was performed for the finished device lot/serial number: (b)(6), and no non-conformances were identified.  at this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Device history lot: a manufacturing record evaluation was performed for the finished device lot/serial number: (b)(6), and no non-conformances were identified.

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO -NS
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9530418
• MDR Text Key: 192144236
• Report Number: 1221934-2019-60194
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020607
• UDI-Public: 10886705020607
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 284580
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/27/2020
• Patient Sequence Number: 1