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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS
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CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number 261221
Device Problem Mechanical Problem (1384)
Patient Problem Brain Injury (2219)
Event Date 07/09/2021
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported a surgeon was performing a craniotomy when the disposable perforator came apart at the blue plastic sleeve/housing.The shaft and blue plastic sleeve/housing remained attached to the power drill itself but the rest of the perforator remained lodged in the patient¿s skull causing a local contusion in the frontal lobe (not clinically significant).There was a 5 minutes surgical delay.
 
Manufacturer Narrative
The perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.The unit had a shifted sleeve that was exposing the pin, likely from a bad weld.Ifu testing procedure was performed.The sleeve had to be shifted back into position and then it passed the spring test and functioned as designed.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release: the unit was found to not perform as intended.In the failure analysis that was performed, the returned unit did not work as intended, the unit successfully drilled two holes in the board then came apart on the 3rd drill hole.Unit was put back together and re-tested but came apart again during drilling after successfully making 5 more holes.The complaint could be verified through failure analysis.Per the complaint background, perforator plunged, got stuck and broke.The complaint was confirmed in the complaint investigation.The failure analysis performed confirmed that the unit had a proud weld which likely caused the unit to fail during surgery.Due to the confirmation of this failure, a corrective action has been implemented to investigate this issue.
 
Event Description
N/a.
 
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Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
MDR Report Key12250446
MDR Text Key264266183
Report Number3014334038-2021-00151
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/03/2021
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? No
Device Operator Health Professional
Device Catalogue Number261221
Device Lot NumberJ8999K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Initial Date Manufacturer Received 07/09/2021
Initial Date FDA Received07/29/2021
Supplement Dates Manufacturer Received10/18/2021
Supplement Dates FDA Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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