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

Catalog Number	5450800312
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the device broke at the tip.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 breakage was confirmed.The product was evaluated by product engineering who concluded that based on the images recorded, the tip made contact with a metal object inside the surgical site during use.This runs contrary to the advice detailed in the sonopet system (instruction for use)ifu: ¿do not strike the ultrasonic tip against a metal or surgical object during vibration.¿ it is highly likely that the damage associated with this contact led to the device fracturing during use and may have also been responsible for the frequency alarms described in the complaint description.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the device broke at the tip.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: 10656984
• Report Number: 0001811755-2020-02642
• Device Sequence Number: 19509410
• Product Code: LFL
• UDI-Device Identifier: 37613252026724
• UDI-Public: 37613252026724
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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 Catalogue Number: 5450800312
• Device Lot Number: 1000396155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1