MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRAIGHT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450800307
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not available for return.
Event or Problem Description
It was reported that during a surgical procedure, the tip sleeve melted.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, the tip sleeve melted.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the reported product involved with this event was returned for evaluation and the reported failure of a melted sleeve was confirmed.The most likely cause was insufficient irrigation associated with the tubing setup or priming of the irrigation before use.All sonopet 1.0 tips generate heat during normal operation.To that end, adequate irrigation must be used with part numbers to prevent unintended thermal damage to the patient and the device.The instruction for use(ifu) 5450-820-700 rev.H, of the handpiece for use with this tip & sleeve contains the following warning; "¿ applied part may generate heat.Use care to avoid tissue damage due to unintended contact.Always provide adequate irrigation to the tip.".

• Brand Name: STRAIGHT
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10862734
• Report Number: 0001811755-2020-03211
• Device Sequence Number: 19491762
• Product Code: LFL
• UDI-Device Identifier: 37613252026670
• UDI-Public: 37613252026670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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 Catalogue Number: 5450800307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1