Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-PUERTO RICO FEMORAL CANAL TIP; LAVAGE, JET
  • 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-PUERTO RICO FEMORAL CANAL TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210008000
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/21/2014
Event Type  malfunction  
Event Description
It was reported that the femoral canal tip was being used in a procedure when it broke off and fell into the surgical site.The tip was removed by hand and the procedure was completed successfully with no patient or user injuries, and no adverse consequences.
 
Manufacturer Narrative
Discarded by user facility.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FEMORAL CANAL TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3811331
MDR Text Key4471749
Report Number0001811755-2014-01776
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2014
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 Health Professional
Device Catalogue Number0210008000
Device Lot Number13241012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/21/2014
Initial Date FDA Received05/15/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-