• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ACM KIT W/ FEMORAL BREAKAWAY NOZZLE; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11218414
MDR Text Key228447721
Report Number0001811755-2021-00325
Device Sequence Number1
Product Code JDZ
UDI-Device Identifier34546540055409
UDI-Public34546540055409
Combination Product (y/n)N
Number of Events Reported3
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 Number0306563000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/31/2020
Initial Date FDA Received01/22/2021
Supplement Dates Manufacturer Received12/31/2020
Supplement Dates FDA Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-