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-KALAMAZOO ASEPTIC BATTERY HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  • 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 ASEPTIC BATTERY HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4126120000
Device Problems Disassembly (1168); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2014
Event Type  malfunction  
Event Description
It was reported that while aseptic battery housing opened up during a medical procedure and non-sterile battery fell on the sterile surgical site.It was removed by hand using gloves.The housing was being used with system 5 sagittal saw.The procedure was completed without a clinically significant delay; no adverse consequences or medical intervention were reported with this event.
 
Event Description
It was reported that while aseptic battery housing opened up during a medical procedure and non-sterile battery fell on the sterile surgical site.It was removed by hand using gloves.The housing was being used with system 5 sagittal saw.The procedure was completed without a clinically significant delay; no adverse consequences or medical intervention were reported with this event.
 
Manufacturer Narrative
The reported event, housing door opened during use, was duplicated.The technician confirmed that the housing opened during functional testing.The latch was disassembled and debris was found around the latch mechanism.A worn rubber seal and broken internal contact were also found.A degraded o¿ring can be caused by improper sterilization.Device was placed in parts retention.
 
Manufacturer Narrative
The device has been received, but the evaluation has not yet begun.Additional information may be submitted once the quality investigation is complete.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASEPTIC BATTERY HOUSING
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3863913
MDR Text Key4509610
Report Number0001811755-2014-02103
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K972367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4126120000
Device Lot Number11117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
4208000000, SYSTEM 5 SAGITTAL SAW, S/N (B)(4); 4126110000, NON-STERILE LARGE BATTERY, S/N (B)(4)
-
-