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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5/32IN INCH DRILL WITH KEY; ARTHROSCOPE
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5/32IN INCH DRILL WITH KEY; ARTHROSCOPE Back to Search Results
Model Number 4100132000
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 04/08/2021
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device came apart during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Corrected data: d9/h3 h3 other text : device not available.
 
Event or Problem Description
The user facility reported that the device came 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
5/32IN INCH DRILL WITH KEY
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11769679
Report Number3015967359-2021-00769
Device Sequence Number4168696
Product Code HRX
UDI-Device Identifier04546540068187
UDI-Public04546540068187
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K943323
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) 07/08/2021
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 Number4100132000
Device Catalogue Number4100132000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/08/2021
Supplement Date Received by Manufacturer07/07/2021
Initial Report FDA Received Date05/04/2021
Supplement Report FDA Received Date07/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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