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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ELECTRIC SYSTEM 6 DUAL TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO ELECTRIC SYSTEM 6 DUAL TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 6295000000
Device Problem Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2020
Event Type  malfunction  
Manufacturer Narrative
This is a follow-up report to a previously submitted manufacturer summary report (msr). The previous report reference # is (b)(4). Please see 0001811755-2020-01935 for the originally reported event.
 
Event Description
It was reported during servicing at the user facility that the device unintentionally activates. There was no patient involvement or adverse consequences associated with the event.
 
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Brand NameELECTRIC SYSTEM 6 DUAL TRIGGER ROTARY HANDPIECE
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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key12231549
MDR Text Key263917554
Report Number0001811755-2021-00781
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6295000000
Device Catalogue Number6295000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2020
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

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