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

Catalog Number	19102000
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Machine started smoking inside operating room and cleaning crew noticed.This happened after hours and did not occur during a case.
Additional 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 or Problem 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®
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8409372
• Report Number: 0009610622-2019-00106
• Device Sequence Number: 240331
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other