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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

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INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Model Number 261221
Device Problem Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Date 02/25/2023
Event Type  malfunction  
Event Description
A facility reported a perforator (id 261221) was stuck in the bone, a matchstick craniotome was used to go around the perforator to release it.The event led to 10 minutes surgical delay.The drill used with the perforator was an electric stryker drill.The perforator did click in place with the drill.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Manufacturer Narrative
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 - a visual inspection showed the unit was received disassembled and heavily soiled, with a portion of the patient's skull still attached.Furthermore, the bottom of the sleeve melted as can be seen by the thin blue ring attached to the hudson end of the device.This is likely due to the operator of the electric drill trying to free the stuck unit by continuing to drill, heating the sleeve due to the increased frictional forces.A spring test could not be performed "as is" due to being received disassembled.Unit had organic material removed and the sleeve replaced.Once the unit was cleaned and re-sleeved it passed the spring test as designed.Functional test performed after being re-sleeved.The unit successfully drilled 5 holes with no issues and passed the drill test.The failure could not be replicated therefore, the complaint condition could not be confirmed.However it is noted that the disassembly was likely due to the mechanical forces used whilst trying to remove the unit from the patient's skull.Root cause remains undetermined.Product was received for analysis and the analyst could not confirm the complaint condition.
 
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Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA
Manufacturer (Section G)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
mansfield MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key16806865
MDR Text Key313930324
Report Number3014334038-2023-00056
Device Sequence Number1
Product Code HBF
UDI-Device Identifier10381780513599
UDI-Public10381780513599
Combination Product (y/n)N
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/12/2023
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 Model Number261221
Device Catalogue Number261221
Device Lot Number6821884
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/05/2023
Initial Date FDA Received04/25/2023
Supplement Dates Manufacturer Received06/29/2023
Supplement Dates FDA Received07/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2022
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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