MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3 FOOTSWITCH *EA; FOOT-SWITCH, ELECTRICAL

Catalog Number 225023

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Not Applicable (3189)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.Udi: (b)(4).

Event Description

It was reported by the sales rep via email that during a shoulder scope procedure the vapr iii foot pedal did not operate normally.The blue pedal would not function when pressed.The procedure was completed with another pedal.There was a one minute surgical delay to switch the pedals and no patient harm.

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary
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> the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.The lot number of the complaint device indicates it is 15 years old.The likely root cause of the reported problem is fair wear and tear due to age and use, however without the return of the device a definitive root cause cannot be determined.A manufacturing record evaluation was performed for the finished device lot number (0407159), 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 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.

• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9106443
• MDR Text Key: 196397432
• Report Number: 1221934-2019-58463
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705009114
• UDI-Public: 10886705009114
• Combination Product (y/n): N
• PMA/PMN Number: K041135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225023
• Device Lot Number: 0407159
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1