• 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-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT

  • 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-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT Back to Search Results
Catalog Number UNK_ICO
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 12/08/2015
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that during service conducted at the manufacturer a broken bur was found inside the attachment.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
The quality investigation is complete.
 
Event Description
It was reported that during service conducted at the manufacturer a broken bur was found inside the attachment.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Type of Device
UNKNOWN
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
dervillia murphy
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key5322043
MDR Text Key34919603
Report Number0001811755-2015-04736
Device Sequence Number1
Product Code HTT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/08/2015
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 Other
Device Catalogue NumberUNK_ICO
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/08/2015
Initial Date FDA Received12/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/05/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-