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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number UNK_INS
Device Problem Device Remains Activated (1525)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2018
Event Type  malfunction  
Event Description
It was reported that after a surgical procedure at the user facility, the device would not stop running.The user facility reported that the procedure was completed successfully without a delay and that there were no adverse consequences or medical interventions.
 
Event Description
It was reported that after a surgical procedure at the user facility, the device would not stop running.The user facility reported that the procedure was completed successfully without a delay and that there were no adverse consequences or medical interventions.
 
Manufacturer Narrative
Follow up being submitted for investigation results and corrected information.Device not received for evaluation.
 
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Brand Name
UNKNOWN_INSTRUMENTS_PRODUCT
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7229455
MDR Text Key98633486
Report Number0001811755-2018-00376
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_INS
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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