MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CORE IRRIGATION CASSETTE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5400050001
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer discarded product.
Event or Problem Description
The user facility reported that there was a hair in the package found during preparation of a surgery.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: CORE IRRIGATION CASSETTE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 8351344
• Report Number: 0001811755-2019-00574
• Device Sequence Number: 207031
• Product Code: ERL
• UDI-Device Identifier: 34546540427299
• UDI-Public: 34546540427299
• Combination Product (Y/N): N
• PMA/510(K) Number: K112593
• 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
• Report Date (Section B): 02/19/2019

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: 5400050001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1