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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN SHURTLEFF, INC.; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
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CODMAN SHURTLEFF, INC.; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED) Back to Search Results
Lot Number J4593J
Device Problems Mechanical Problem (1384); Failure to Auto Stop (2938); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 03/11/2020
Event Type  malfunction  
Event Description
Patient was brought to the operating room as a 9999 craniotomy for decompression.Once incision was made the medtronic drill and codman perforator were used to make burr holes in the skull to remove the bone.The first two burr holes that were made without incident.On the third burr hole the drill did not stop and "plunged" because the safety mechanism on the drill was not working.The drill was being used by the neuro surgical chief resident at the time of this incident.Attending physician was also present.A second perforator was opened at this time to make the last burr hole.Both perforators, drill with attachments and drill console were pulled from service.
 
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Type of Device
DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
Manufacturer (Section D)
CODMAN SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key10669745
MDR Text Key211038458
Report Number10669745
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot NumberJ4593J
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2020
Event Location Hospital
Date Report to Manufacturer10/13/2020
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age13505 DA
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