MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO HOWMEDICA MIX KIT BOWL WITH SPATULA; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	6201003410
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the a foreign material was inside the blister package during a procedure.There was no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that the a foreign material was inside the blister package during a procedure.There was no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Product is lost by the customer.

• Brand Name: HOWMEDICA MIX KIT BOWL WITH SPATULA
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 8466443
• Report Number: 0001811755-2019-01021
• Device Sequence Number: 11510586
• Product Code: JDZ
• UDI-Device Identifier: 34546540257803
• UDI-Public: 34546540257803
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 6201003410
• Device Lot Number: 18179012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1