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

Model Number	1910-2000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
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
It was reported that for a procedure to place sonic anchors in the patient's right foot, it was discovered that the 3-prong socket in the back of the generator was sunken in and the unit would not turn on.Competitor anchors were used to complete the case successfully with a delay of approximately 5 minutes.
Event or Problem Description
It was reported that for a procedure to place sonic anchors in the patient's right foot, it was discovered that the 3-prong socket in the back of the generator was sunken in and the unit would not turn on.Competitor anchors were used to complete the case successfully with a delay of approximately 5 minutes.
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), stryker t&e does neither have the equipment nor the electronics specialists for a comprehensive inspection of the generator.Results: visual inspection: the sonicfusion console was received with half of the warranty seal missing.External damages were noticed during visual inspection.Functional inspection: then a power cable was plugged in but the console was unable to power on.Using a multimeter the fuses were verified to have continuity.The main board was inspected and confirmed damage to power inlet.The root cause could be possible user misuse.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: 10781443
• Report Number: 0009610622-2020-00677
• Device Sequence Number: 19101215
• 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): 01/13/2021

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: 17K520324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1