MAUDE Adverse Event Report: DEPUY MITEK LLC US FOOT PEDAL(FMS VUE/NEXTRA); FOOT-SWITCH, ELECTRICAL

Model Number 283573

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

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.Udi: (b)(4).

Event Description

It was reported via the affiliate that the fms was pulled out to use in an a/s case.Blood and saline was leaking out of the back of the footpedal.Level 2 ortho nurse said that she had asked ns whether they had been bagging the pedal for cases and they said they had.Ns reported that there was a considerable amount of bloody and fluid leaking out.Footpedal discarded as bmt would not look at footpedal due to amount of blood, and cssd also could not decontaminate due to electrics.Hospital used an alternative footpedal to complete cases.No delay was reported.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary: according to the information provided, it was reported that during that the blood and saline was leaking out of the back of the footpedal, that there was a considerable amount of bloody and fluid leaking out.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number: g38ay1772, and no non-conformances were identified.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.Device history lot: a manufacturing record evaluation was performed for the finished device lot number: g38ay1772, and no non-conformances were identified.

• Brand Name: FOOT PEDAL(FMS VUE/NEXTRA)
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9665085
• MDR Text Key: 204070625
• Report Number: 1221934-2020-00466
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705017010
• UDI-Public: 10886705017010
• 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
• Report Date: 01/28/2020

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: 283573
• Device Catalogue Number: 283573
• Device Lot Number: G38AY1772
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 04/20/2020
• Patient Sequence Number: 1