• 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 SABO2 SAG SAW 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 SABO2 SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 4408000000
Device Problems Material Disintegration (1177); Fluid Leak (1250)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2020
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 1 event was reported for this quarter. Product return status: 1 device investigation type has not yet been determined. Additional information: 1 device was not labeled for single-use. 1 device was not reprocessed or reused.
 
Event Description
This report summarizes 1 malfunction event in which the device was reportedly leaking. 1 event had no patient involvement; no patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABO2 SAG SAW
Type of DeviceINSTRUMENT, 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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key10350634
MDR Text Key201364632
Report Number0001811755-2020-02035
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4408000000
Device Catalogue Number4408000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-