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

Catalog Number 19102000

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

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: visual inspection: the sonicfusion console was received with the warranty seal broken.A dent on the back of the cover was noticed.Also scratches along with labels.Functional inspection: then a power cable was plugged in but the console was unable to power on.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.The root cause is the main board which could be due to a possible non-functioning component.Pac (product assessment center): review of capa database and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated non-function was addressed adequately.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

Event Description

As reported: "plugged in power cord for sonic anchor generator and it never powered up.Tried second power generator cord and still did not turn on".

Manufacturer Narrative

Correction - please refer to d9/h3.

Event Description

As reported: "plugged in power cord for sonic anchor generator and it never powered up.Tried second power generator cord and still did not turn on".

• Brand Name: SONICFUSION¿ ULTRASONIC GENERATOR SONICPIN®
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18026185
• MDR Text Key: 326848068
• Report Number: 0009610622-2023-00376
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

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: 15J046834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female