MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP AUTOPLEX SYSTEM W/ VERTAPLEX HVV; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number 0607687000

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2022

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.

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: AUTOPLEX SYSTEM W/ VERTAPLEX HVV
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16261893
• MDR Text Key: 308380765
• Report Number: 3015967359-2023-00180
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 37613252039250
• UDI-Public: 37613252039250
• 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: 01/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0607687000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2022
• 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