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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AO SMALL DRILL; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO AO SMALL DRILL; ARTHROSCOPE Back to Search Results
Model Number 4100110000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/17/2021
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device was falling apart during testing prior to a procedure. there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
H3 other text : device not accessible for testing.
 
Event or Problem Description
The user facility reported that the device was falling apart 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 SMALL DRILL
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key12432529
Report Number3015967359-2021-01971
Device Sequence Number3245120
Product Code HRX
UDI-Device Identifier04546540068156
UDI-Public04546540068156
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number4100110000
Device Catalogue Number4100110000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/17/2021
Supplement Date Received by Manufacturer10/05/2021
Initial Report FDA Received Date09/07/2021
Supplement Report FDA Received Date10/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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