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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AO LARGE REAMER; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO AO LARGE REAMER; ARTHROSCOPE Back to Search Results
Model Number 4100210000
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2020
Event Type  malfunction  
Event Description
The user facility reported that the device was missing a component during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
AO LARGE REAMER
Type of Device
ARTHROSCOPE
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 Key11089085
MDR Text Key224277652
Report Number0001811755-2020-03581
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04546540068217
UDI-Public04546540068217
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4100210000
Device Catalogue Number4100210000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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