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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

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CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC. Back to Search Results
Catalog Number 26-1221
Device Problem Dull, Blunt (2407)
Patient Problem No Code Available (3191)
Event Date 02/28/2013
Event Type  malfunction  
Event Description
The sales rep reported dr (b)(6) said the perforator was not sharp enough to cut through the skull.No delay in surgery reported as a result of this incident.
 
Manufacturer Narrative
Upon completion of the investigation, it was noted that as received the drill had dried contamination across all sides of the functional area of the drill.The returned perforator was visually inspected as received, disassembled and cleaned, and then visually and dimensionally inspected.No discrepancies were found.The perforator was reassembled and was functionally tested for cutting and drilling.It was found to meet specification requirements.The reported condition could not be duplicated.Review of the device history record has found no discrepancies.At this time, the complaint is considered to be closed.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC.
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
new bedford industrial park
new bedford MA 02745
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key3790534
MDR Text Key16059859
Report Number1226348-2014-11546
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
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 Health Professional
Device Catalogue Number26-1221
Device Lot NumberME020S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2013
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/05/2014
Initial Date FDA Received05/05/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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