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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4" DRILL WITH KEY ARTHROSCOPE

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STRYKER INSTRUMENTS-KALAMAZOO 1/4" DRILL WITH KEY ARTHROSCOPE Back to Search Results
Model Number 4100131000
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Event Description
The user facility reported that the device was disassembled during testing prior to a procedure. Attempts are being made to obtain additional information about the event; no further information has been received.
 
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Brand Name1/4" DRILL WITH KEY
Type of DeviceARTHROSCOPE
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
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key12752781
MDR Text Key280171783
Report Number3015967359-2021-02490
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4100131000
Device Catalogue Number4100131000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
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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