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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POWEREAM AO; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO POWEREAM AO; ARTHROSCOPE Back to Search Results
Model Number 4405235000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/28/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device fell apart during testing prior to a procedure. there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device fell 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
POWEREAM AO
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10364630
Report Number0001811755-2020-02053
Device Sequence Number2888292
Product Code HRX
UDI-Device Identifier07613327004144
UDI-Public07613327004144
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/19/2020
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 Number4405235000
Device Catalogue Number4405210000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 07/28/2020
Supplement Date Received by Manufacturer11/19/2020
Initial Report FDA Received Date08/04/2020
Supplement Report FDA Received Date11/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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