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 SMARTLIFE LARGE ASPTC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-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 SMARTLIFE LARGE ASPTC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7126120000
Device Problems Disassembly (1168); Battery Problem (2885); Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2015
Event Type  malfunction  
Manufacturer Narrative
The device has not been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
 
Event Description
It was reported that the aseptic housing broke during a medical procedure and top housing is detached from the bottom housing.The procedure was completed successfully using back-up equipment.No medical intervention and no adverse consequences were reported with this event.A delay of fifteen minutes was reported due to the malfunction of the battery housing.
 
Manufacturer Narrative
The reported event, battery housing came apart, was confirmed.The service technician observed that the top and bottom housings had fractured at the weld, as a loose component symptom failure was found.The device was discarded by the manufacturer.
 
Event Description
It was reported that the aseptic housing broke during a medical procedure and top housing is detached from the bottom housing.The procedure was completed successfully using back-up equipment.No medical intervention and no adverse consequences were reported with this event.A delay of fifteen minutes was reported due to the malfunction of the battery housing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SMARTLIFE LARGE ASPTC HOUSING
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-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 Key5067153
MDR Text Key25354849
Report Number0001811755-2015-03305
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Followup
Report Date 08/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7126120000
Device Lot Number14337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-