MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PAYNER 360; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450-800-312
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, the tip of sleeve melted and a piece had to be removed from the surgical site.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 event, for a melted sleeve, was not confirmed as the device was not returned for evaluation.Without the device, the root cause cannot be determined.H3 other text : device not available for return.
Event or Problem Description
It was reported that during a surgical procedure, the tip of sleeve melted and a piece had to be removed from the surgical site.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.

• Brand Name: PAYNER 360
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11039419
• Report Number: 0001811755-2020-03517
• Device Sequence Number: 13769333
• Product Code: LFL
• UDI-Device Identifier: 37613252026724
• UDI-Public: 37613252026724
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 5450-800-312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1