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

Catalog Number 19102000

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

When running the test on the generator it would flash 100% and the "x" at the same time, then require a test again.Could not get past the test screen to use for procedure.Event occurred in operating room while patient was under anesthesia for a kidner procedure.Procedure was completed successfully with no adverse consequences or surgical delay reported.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned, and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Review of complaint history and risk analysis performed did not identify any conspicuity.The review of the risk assessment for the failure mode 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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

Event Description

When running the test on the generator it would flash 100% and the "x" at the same time, then require a test again.Could not get past the test screen to use for procedure.Event occurred in operating room.While patient was under anesthesia for a kidner procedure.Procedure was completed successfully with no adverse consequences or surgical delay reported.

• 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
• MDR Report Key: 8601757
• MDR Text Key: 145115161
• Report Number: 0009610622-2019-00245
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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: Health Professional
• Device Catalogue Number: 19102000
• Device Lot Number: 15J046794
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1