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

Catalog Number 19102000

Device Problems Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591)

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

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

As reported: "an error message occurred.The machine will not go past the error screen".Reporter indicated there were no adverse consequences to the patient/ user.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the sonicfusion console was received with the warranty seal broken.No external damages were noticed, only scratches, scuff marks, stickers and residue from previous stickers were noticed.A multimeter was used to test the fuses and were found to have continuity.Then the console was powered on and was unable to complete the boot process due to a l01000 lockdown error.A known good main board was installed, the console was powered on and able to complete the boot process without any issues.The complaint main board was inspected for damages such as burnt components.None were seen.The only possible root cause can be main board being the non-conforming component because all the cables were properly seated before connecting the known good main board.The reason for failure of main board was insufficient voltage supplied to the device which led to l01000 lockdown error.The failure(s) identified in the investigation is consistent with the complaint record.If any further information is provided, the complaint report will be updated.

Event Description

As reported: "an error message occurred.The machine will not go past the error screen".Reporter indicated there were no adverse consequences to the patient/ user.

• 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: 8767255
• MDR Text Key: 150402371
• Report Number: 0009610622-2019-00530
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: 15J046824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1