MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRAIGHT IRRIGATION CLIP; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5450040011
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device overheated during procedure.There was no known patient impact, no known delay, no known medical intervention, and no known adverse consequences.
Event or Problem Description
The user facility reported that the device overheated during procedure.There was no known patient impact, no known delay, no known medical intervention, and no known adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The user facility reported that the device overheated during procedure.There was no known patient impact, no known delay, no known medical intervention, and no known adverse consequences.
Additional Manufacturer Narrative
H6, results code and conclusion code corrected.After investigation and further information about this event, this device is a concomitant device and is listed as concomitant on mdr 0001811755-2020-00681.

• Brand Name: STRAIGHT IRRIGATION CLIP
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9820272
• Report Number: 0001811755-2020-00679
• Device Sequence Number: 1213148
• Product Code: ERL
• UDI-Device Identifier: 07613327116571
• UDI-Public: 07613327116571
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2020

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 Model Number: 5450040011
• Device Catalogue Number: 5450040011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 08/13/2020; 09/04/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 08/13/2020; 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1