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

Model Number 1910-1001

Device Problem Failure to Power Up (1476)

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

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition is unknown.

Event Description

As reported: "opened set, and wires were burnt.Handpiece was non-operable.Patient outcome was not affected!".

Event Description

As reported: "opened set, and wires were burnt.Handpiece was non-operable.Patient outcome was not affected!".

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?
• Type of Device: 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
• MDR Text Key: 191676858
• Report Number: 0009610622-2019-00946
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613327096019
• UDI-Public: 07613327096019
• Combination Product (y/n): N
• PMA/PMN Number: K143063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1910-1001
• Device Catalogue Number: 19101001
• Device Lot Number: 10091360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1