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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO F1 U-DRIVER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO F1 U-DRIVER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 1900099000
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/25/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device was leaking after sterilization.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 was leaking after sterilization.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
F1 U-DRIVER
Common Device Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8619691
Report Number0001811755-2019-01710
Device Sequence Number380840
Product Code HWE
UDI-Device Identifier07613327072037
UDI-Public07613327072037
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
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) 07/12/2019
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 Catalogue Number1900099000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2019
Initial Date Received by Manufacturer 04/25/2019
Supplement Date Received by Manufacturer07/12/2019
Initial Report FDA Received Date05/17/2019
Supplement Report FDA Received Date07/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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