MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/ CANCELLOUS NOZZLE & TIBIAL PRESS. TIP; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number 0606583000

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device was not available for evaluation.Additional information: 1 device was labeled for single-use.1 device was not reprocessed or reused.Device not returned.

Event Description

This report summarizes 1 malfunction event in which the device had debris in sterile package.1 event had patient involvement; no patient impact.

• Brand Name: REVOLUTION CMS W/ CANCELLOUS NOZZLE & TIBIAL PRESS. TIP
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; PR 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; PR 00615
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 9997098
• MDR Text Key: 191038531
• Report Number: 0001811755-2020-01066
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 34546540447907
• UDI-Public: 34546540447907
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0606583000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1