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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 Failure to Auto Stop (2938)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The affiliate advised that the perforators (2 perforators) will not be returned.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed.Device not available.
 
Event Description
On (b)(6), the safety mechanism did not work and it continued to rotate without stopping when the "transforation" was performed by the drill's cutting edge at 2 times in a row.The first time used the product after re-sterilization, so it was suspected that re-sterilization was the cause of the issue.The second time used it as a brand new but the safety mechanism did not work as well.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.The products will not be returned to your site.
 
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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 Key6998706
MDR Text Key91337132
Report Number1226348-2017-10805
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/18/2017
Initial Date FDA Received11/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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