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

Catalog Number 284580

Device Problem Overfill (2404)

Patient Problem Not Applicable (3189)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or.

Event Description

It was reported by the sales rep via phone, who was present during the case, that the fms duo pump tube chamber filled up to the top with no release and the pump continued to run.They had to replace the pump with another like device to complete the case.This caused a delay of approximately five minutes with no patient harm.The pump will be returned for evaluation.There was patient involvement reported.There were no 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

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary
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> the complaint device was received and evaluated at the service and repair center.Operational and diagnostic analysis does not confirm the reported issue (pump tube chamber filled up to the top).However, the repair and testing of the unit will not be completed at this time because there is no need for it in the pool due to excess units in the pool at this time.Unit placed into long term hold.Furthermore, the service history has been reviewed in lieu of the manufacturing record evaluation for this device since it was previously serviced.The device was last serviced on january 11th, 2019 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.Udi:(b)(4).

• 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: 8587645
• MDR Text Key: 145007239
• Report Number: 1221934-2019-57077
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• 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: 05/13/2019
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1