MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SONICFUSION¿ HANDPIECE SONICPIN?; PIN, FIXATION, SMOOTH

Model Number	1910-1001
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: "opened set, and wires were burnt.Handpiece was non-operable.Patient outcome was not affected!".
Event or Problem Description
As reported: "opened set, and wires were burnt.Handpiece was non-operable.Patient outcome was not affected!".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.No indications of material, manufacturing or design related problems were found during the investigation.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.

• Brand Name: SONICFUSION¿ HANDPIECE 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: 9394939
• Report Number: 0009610622-2019-00946
• Device Sequence Number: 1954010
• Product Code: HTY
• UDI-Device Identifier: 07613327096019
• UDI-Public: 07613327096019
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• 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): 02/12/2020

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: Health Professional
• Device Model Number: 1910-1001
• Device Catalogue Number: 19101001
• Device Lot Number: 10091360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1