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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DHS REAMER ATTACHMENT; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO DHS REAMER ATTACHMENT; ARTHROSCOPE Back to Search Results
Model Number 4100215000
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 05/17/2021
Type of Reportable Event Malfunction
Event or Problem Description
The device had a piece missing during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Correction: d2b and h6 results code.
 
Event or Problem Description
The device had a piece missing during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
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Brand Name
DHS REAMER ATTACHMENT
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11859702
Report Number3015967359-2021-00923
Device Sequence Number11595390
Product Code HWE
UDI-Device Identifier07613327116397
UDI-Public07613327116397
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K943323
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/21/2021
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 Other
Device Model Number4100215000
Device Catalogue Number4100215000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Initial Date Received by Manufacturer 05/17/2021
Supplement Date Received by Manufacturer05/20/2021
Initial Report FDA Received Date05/20/2021
Supplement Report FDA Received Date05/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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