MAUDE Adverse Event Report: DEPUY MITEK VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE; VAPR ELECTRODES

Catalog Number 225370

Device Problems Device Or Device Fragments Location Unknown (2590); Sparking (2595)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

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

The affiliate reported via email the patient had recurrent acromioclavicular dislocation in the past three years.He had acromioclavicular fixation operation on (b)(6) 2017.However, the device's ceramic head broke during using.The broken pieces were not found and could not determine the location.Changed the same like product to complete the operation.It prolonged operation time about half hour.Now the patient is in good condition.

Manufacturer Narrative

The complaint device was received and evaluated.Visual inspection of the device revealed a melted and burnt manifold from the 4 o¿clock to 7 o¿clock positions.Upon further visual observation, the ceramic material on the active tip is broken off from the 4 o¿clock to 7 o¿clock positions, thus confirming this complaint.The metal faceplate of the active tip was also found to be crooked.Saline residue was found inside the suction tube.Visual signs of activation were found at the active tip.Plugging the device into the generator, all defaults were displayed.Sparking was identified in both cut and coag.Modes due to the broken ceramic head.If the sparking and arcing occurred during use, it may have contributed to the ceramic head to burn and deteriorate, causing the ceramic material to weaken and eventually brake.Other than this possibility a specific root cause cannot be determined.The supplier completed a capa investigation to address this failure, and training requirements were updated to be performed on a six month basis.The dhr review indicated that this lot of devices was processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed two other complaints (four total devices) of this lot number with a similar failure mode but one complaint with a different root cause for this lot of devices released to distribution.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.(b)(4).

• Brand Name: VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE
• Type of Device: VAPR ELECTRODES
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6709278
• MDR Text Key: 79888626
• Report Number: 1221934-2017-10354
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 225370
• Device Lot Number: U1602047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2017
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other