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 ORTHOPAEDICS-CORK COLORADO NEEDLE, 3" STRAIGHT SLEEVE, 3MM 45 ANG; INSTRUMENT
  • 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 ORTHOPAEDICS-CORK COLORADO NEEDLE, 3" STRAIGHT SLEEVE, 3MM 45 ANG; INSTRUMENT Back to Search Results
Catalog Number E1133
Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/08/2014
Event Type  malfunction  
Event Description
It was reported that whilst in surgery, the tip of a colorado needle has broken off.The tip could not be found and the patient required an x-ray to see if it had fallen in the wound.The x-ray was inconclusive and they are still unaware of where the tip of the needle is.This resulted in a delay to surgery.
 
Manufacturer Narrative
Device not available for evaluation.If additional information is received it will be reported on a supplemental report.
 
Manufacturer Narrative
The visual investigation of the picture provided confirmed that the tip of the needle is missing/broken off.Because the complained device was not returned it was not possible to perform further investigations.The review of the related manufacturing (by the supplier) and inspection documents (by (b)(4)) showed that the lot was manufactured according to the specification.The supplier team has completed a thorough investigation of all the associated processing steps and the related materials (inputs and outputs).Based on the available information, the root cause for the reported event could not be determined.As per statistical evaluation there were no indications for any systematic, design, material or manufacturing related issue.
 
Event Description
It was reported that whilst in surgery, the tip of a colorado needle has broken off.The tip could not be found and the patient required an x-ray to see if it had fallen in the wound.The x-ray was inconclusive and they are still unaware of where the tip of the needle is.This resulted in a delay to surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COLORADO NEEDLE, 3" STRAIGHT SLEEVE, 3MM 45 ANG
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
jamshed badarpura
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key3841530
MDR Text Key4411955
Report Number0008010177-2014-00142
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K033232
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE1133
Device Lot Number13275017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/08/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/21/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-