MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ACM KIT W/ FEMORAL BREAKAWAY NOZZLE; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number 0306563000

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 12/31/2020

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: 3 events were reported for this quarter.Product return status: 3 device investigation types have not yet been determined.3 devices were labeled for single-use.3 devices were not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events in which the device had debris in sterile package.2 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h10 3 previously reported events are included in this follow-up record.Product return status 2 devices were received.1 device was not available for evaluation.

Event Description

This report summarizes 3 malfunction events in which the device had debris in sterile package.- 1 event had no patient involvement; no patient impact.- 2 events had patient involvement; no patient impact.

• Brand Name: ACM KIT W/ FEMORAL BREAKAWAY NOZZLE
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; highway #3, km 130.2; portage MI 49002
• MDR Report Key: 11218414
• MDR Text Key: 228447721
• Report Number: 0001811755-2021-00325
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 34546540055409
• UDI-Public: 34546540055409
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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
• Device Operator: No Information
• Device Catalogue Number: 0306563000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1