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

Catalog Number 284580

Device Problems Increase in Pressure (1491); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).(b)(6).Associated mr#: 1221934-2018-54504.

Event Description

It was reported by the customer as following that:during an unknown procedure; the device rised in pressure by itself without using the shaver.Spare device used to complete the procedure.The speed of the spare device increased and decreased randomly and has a strange noise.Procedure successfully completed.Harm to the patient reported; hematoma on patient shoulder.No further information available.Delay reported but customer was not able to know if it was less or more than 30 minutes.Loaner requested.

Event Description

It was reported by the customer as following that: during an unknown procedure; the device rised in pressure by itself without using the shaver.Spare device used to complete the procedure.The speed of the spare device increased and decreased randomly and has a strange noise.Procedure successfully completed.Harm to the patient reported; hematoma on patient shoulder.No further information available.Delay reported but customer was not able to know if it was less or more than 30 minutes.

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.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.Evaluation statement: the complaint device was received at service center for service and repair.The reported failure could not be duplicated and the complaint cannot be confirmed.Regular maintenance was performed and the worn tips were replaced.The testing of the unit was completed per the service manual.The unit passed all functional tests and is fully operational.A review of batch history for each legacy fms product complaint is not possible since legacy manufacturing no longer exists.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.Udi: (b)(4).Associated medwatch report number: 1221934-2018-54504.Initial medwatch report was submitted on 8/18/2018; third acknowledgment was not received.Information from initial report included on this follow up report to ensure receipt.

• 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: 7796070
• MDR Text Key: 117575803
• Report Number: 1221934-2018-54503
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2018
• 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: 07/27/2018
• Date Manufacturer Received: 07/27/2018
• Patient Sequence Number: 1