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

Model Number 1910-2000

Device Problem No Display/Image (1183)

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

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a primary foot procedure, the sonic generator was powered up.The touch screen would not register any touches, and a loud, high-pitched noise came from within the generator.The screen then generated an error message: "f00400 system fault".The device was plugged into other outlets and exhibited the same behavior.Surgery was completed successfully with an overall delay of approximately 25 minutes.The rep confirmed that no further information is available.

Manufacturer Narrative

The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Visual inspection: the console was received with the warranty seal broken.Also labels, adhesive residue, smudges were noticed throughout the externally.Also the corner rear of the cover was noticed to be bent.Functional inspection: a footswitch and handpiece were connected to the console and were functional.No issues of a non responsive screen along with a f00400 system fault error were reproduced.In addition with the accessories connected, the console was power cycled and able to complete the boot process without any errors.The probable root cause for frozen screen could be the front panel grounding against the active area of the touchscreen due to misalignment from severe shipping conditions.The probable root cause for the f00400 error is the software rev 2.0, rev.2.2 was released to mitigate errors.Review of complaint history, capa database and risk analysis did not identify any conspicuity.There were no actions in place related to the reported event for the subject product.

Event Description

It was reported that during a primary foot procedure, the sonic generator was powered up.The touch screen would not register any touches, and a loud, high-pitched noise came from within the generator.The screen then generated an error message: "f00400 system fault".The device was plugged into other outlets and exhibited the same behavior.Surgery was completed successfully with an overall delay of approximately 25 minutes.The rep confirmed that no further information is available.

• 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; DE D-24232
• MDR Report Key: 9569766
• MDR Text Key: 174342327
• Report Number: 0009610622-2020-00011
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (y/n): N
• PMA/PMN Number: K091955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1910-2000
• Device Catalogue Number: 19102000
• Device Lot Number: 16H512484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1