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

Model Number	1910-2000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: generator was plugged in and turned on.Generator gave a lockdown error "l01000." additionally reported: surgeon used a competitive product for fixation.
Event or Problem Description
As reported: generator was plugged in and turned on.Generator gave a lockdown error "l01000." additionally reported: surgeon used a competitive product for fixation.
Additional Manufacturer Narrative
The failure(s) identified in the investigation is consistent with the complaint record.The device was examined by the producer stryker endoscopy, san josé (ca), t&e does neither have the equipment nor the electronics specialists for a comprehensive inspection of the generator: results: the sonicfusion console was received with the warranty intact.No external damages were seen.Labels were noticed throughout the console.Functional inspection: then a power cable was plugged in but the console was unable to complete the boot process due to a lo1000 lockdown error.Using a multimeter the fuses were verified to have continuity.The main board was inspected for burnt components.None were seen.Also the flex cables that connect the main board and front board were verified to be properly seated.A known good main board was installed and the console was able to complete the boot process without any errors.The root cause is a main board has a possible non conforming component.Pac: review of capa database and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated potential non-function was addressed adequately.There is already one ongoing action in place related to the reported event for the subject product.

• 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; GM D-24232
• MDR Report Key: 11382439
• Report Number: 0009610622-2021-00310
• Device Sequence Number: 4125349
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/28/2021

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: Health Professional
• Device Model Number: 1910-2000
• Device Catalogue Number: 19102000
• Device Lot Number: 17K538884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1