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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT SMALL BONE POWERED SURGICAL SYSTEMS

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STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT SMALL BONE POWERED SURGICAL SYSTEMS Back to Search Results
Catalog Number 5100015250
Device Problems Break (1069); Unintended Ejection (1234)
Patient Problems Laceration(s) (1946); No Consequences Or Impact To Patient (2199)
Event Date 02/23/2018
Event Type  malfunction  
Event Description
The sales representative reported that the user facility experienced the device releasing the bur into the humerus during a shoulder revision surgery. The doctor made a larger incision to extract the bur from the patient. There was a 60 minute delay reported for the surgery length. Medical intervention to the patient was not reported for this event.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The user facility reported that the surgeon was using the drill to remove cement during a shoulder revision surgery and the bur came out of the attachment and fell into the humerus canal and broke into 2 pieces. There was no patient impact, no medical intervention, and no adverse consequences. There was a 60 minute delay for this event.
 
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Brand NameMICRODRILL SERIES STRAIGHT ATTACHMENT
Type of DeviceSMALL BONE POWERED SURGICAL SYSTEMS
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7373686
MDR Text Key103565458
Report Number0001811755-2018-00547
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100015250
Device Lot Number12280
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/27/2018 Patient Sequence Number: 1
Treatment
1608-002-013 4.7MM ROUND BUR SERIAL UNKNOWN; 1608002013, 4.7MM ROUND BUR, UNKNOWN SERIAL; 6400-015-000 REMB MICRODRILL SERIAL (B)(4); 6400015000 REMB MICRO DRILL, SERIAL (B)(4); THE 1608-002-013 4.7MM ROUND BUR SERIAL UNKNOWN; THE 6400-015-000 REMB MICRODRILL SERIAL (B)(4)
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