MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SONICFUSION ULTRASONIC GENERATOR SONICPIN®; PIN, FIXATION, SMOOTH

Catalog Number 19102000

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Machine started smoking inside operating room and cleaning crew noticed.This happened after hours and did not occur during a case.

Manufacturer Narrative

The device was returned and examined.Visual inspection: the sonicfusion console was received with the warranty seal broken.The console was visually inspected, and it was confirmed, a brown fluid was identified throughout the internal components of the console.This fluid was found to have been ejected by an electrolytic capacitor in the power circuit on the power board of the console.There were no signs of burn.Based on above information.This is likely the result of an electrical short on the power board or external console resulting in heat leading to over-pressurization of the component.Review of complaint history, capa database and risk analysis did not identify any conspicuity.The review of the risk assessment indicated potential non-function was addressed adequately.There were no actions in place related to the reported event for the subject product.A review of the change history revealed the item in question had been manufactured according to current design version.However, no further information is available that would aid in determining a root cause of this occurrence.

Event Description

Machine started smoking inside operating room and cleaning crew noticed.This happened after hours and did not occur during a case.

• Brand Name: SONICFUSION ULTRASONIC GENERATOR SONICPIN®
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8409372
• MDR Text Key: 138676341
• Report Number: 0009610622-2019-00106
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

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: Other
• Device Catalogue Number: 19102000
• Device Lot Number: K0D12DB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other