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

Catalog Number 284580

Device Problem Suction Failure (4039)

Patient Problems Tissue Damage (2104); Not Applicable (3189)

Event Date 02/01/2019

Event Type  Injury  

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).

Event Description

It was reported by the sales rep via email that when the surgeon was doing a shoulder arthroscopic procedure with fms duo+ pump, they heard unusual sounds from it and realized that the sound was due to the tubing hitting against the safety doors.Sales rep then tightened the outflow tubing.It was stated that the patient had started bleeding a lot.They lavaged and increased pressure but there was no clearance on the screen and this went on for several minutes.The surgeon asked sales rep to switch the pump on & off and suggested to start everything from scratch.Sales rep did that but nothing changed.Then sales rep changed the tubing as per the instructions of the surgeon but still there was no clearance on the screen.It was mentioned that the surgeon decided to do the procedure open.Additional information provided by the affiliate via email on (b)(4) 2019 reporting there was a surgical delay of 15 minutes.The affiliate also reported that the date of the event was (b)(6) 2019 and that the surgeon did an open procedure and switched off the arthroscopic machines in order to complete the procedure.It was also reported that the patient was severely bleeding and had a lot of blood clots.

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.

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.The device was received and evaluated at the service center.The reported complaint by the customer was confirmed.It was identified during evaluation that the tips of the device were worn out.The tips and the lexan covers were replaced to correct the reported issue.The worn tips are most likely caused due to usage of the device over time.The worn tips would have caused the customer to experience the reported issue.The device was repaired and returned to the customer.This serialized device (serial: (b)(4)) was manufactured prior to the current manufacturer, therefore a dhr review cannot be performed since the original manufacturer no longer exists and therefore the manufacturer can no longer make any process correction or corrective actions if needed.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).

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.

• 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: 8366573
• MDR Text Key: 137014264
• Report Number: 1221934-2019-56477
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/09/2019
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 02/25/2019; 07/12/2019; 07/15/2019
• Supplement Dates FDA Received: 03/15/2019; 07/12/2019; 07/16/2019
• Patient Sequence Number: 1