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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

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CODMAN & SHURTLEFF, INC DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) Back to Search Results
Model Number 26-1221
Device Problem Failure to Auto Stop (2938)
Patient Problem Insufficient Information (4580)
Event Date 03/11/2021
Event Type  Injury  
Event Description
Failure of drill bit's clutch.Did not stop once reaching the patient's bone and were approximately 1 cm into pt's head.
 
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Brand Name
DISPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC
MDR Report Key11562414
MDR Text Key242391447
Report NumberMW5100224
Device Sequence Number1
Product Code HBF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation No Information
Type of Report Initial
Report Date 03/11/2021
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
Device Operator Lay User/Patient
Device Model Number26-1221
Device Lot NumberJ7871G
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/23/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age76 YR
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