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

Catalog Number	5450800309
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device received but awaiting evaluation.
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 sleeve reported involved in this event was not returned for evaluation.The reported event, for a melted sleeve, was confirmed via photographic evidence provided.Without the sleeve the actual root cause is undetermined in this event.H3 other text : device not available for return.
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 MICRO DIAMETER
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9962071
• Report Number: 0001811755-2020-00910
• Device Sequence Number: 3007429
• Product Code: LFL
• UDI-Device Identifier: 37613252026694
• UDI-Public: 37613252026694
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: 5450800309
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1