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

Catalog Number	5450800307
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
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 tip of the device melted due to heat.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 tip sleeve product reported involved in this event was returned for evaluation.The reported malfunction for a melted sleeve was confirmed on receipt of the product.The product was evaluated by product engineering who concluded that based on the observations during evaluation, the cause of the melted sleeve cannot be determined as there are no indications that the tip was faulty.Based on the tests completed, there is no evidence that either the tip or sleeve were defective which caused the sleeve to melt.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.Alternatively, it is possible that a handpiece with a damaged knuckle could have increased the contact force between the tip and the sleeve.In either instance, neither can be confirmed from this investigation.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the tip of the device melted due to heat.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: STRAIGHT
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10162412
• Report Number: 0001811755-2020-01493
• Device Sequence Number: 11362783
• Product Code: LFL
• UDI-Device Identifier: 37613252026670
• UDI-Public: 37613252026670
• Combination Product (Y/N): N
• 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): 07/24/2020

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 Expiration Date: 07/01/2022
• Device Catalogue Number: 5450800307
• Device Lot Number: 1000328482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1