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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO STEERING DURAGUARD; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO STEERING DURAGUARD; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400210257
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Codes No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/17/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device had a bent foot during installation prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Additional information: d10 device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device had a bent foot during installation prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
PD SERIES MAESTRO STEERING DURAGUARD
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10208459
Report Number0001811755-2020-01595
Device Sequence Number2095398
Product Code ERL
UDI-Device Identifier04546540469267
UDI-Public04546540469267
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/21/2020
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 Number5400210257
Device Catalogue Number5400210257
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Initial Date Received by Manufacturer 06/17/2020
Supplement Date Received by Manufacturer10/20/2020
Initial Report FDA Received Date06/29/2020
Supplement Report FDA Received Date10/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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