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

Model Number	1910-2000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
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
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.
Additional 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 or Problem 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®
• Common Device Name: 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
• Report Number: 0009610622-2020-00011
• Device Sequence Number: 535572
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 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
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1