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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
Catalog Number 261221
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2024
Event Type  malfunction  
Event Description
A physician reported a codman perforator (b)(6) drill disassembled when pulling the device from cranium after making the third burr hole.The procedure was completed with a replacement product available, and all parts were recovered.No surgical delay was reported.No further information was provided.According to information provided, it is unknown if any part fell into the surgical site.It is unknown if the drill is electric or pneumatic.It is also unknown if the perforator clicked in place in the drill, and if the recommended spring tests were performed between each burr hole.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
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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 Key18966530
MDR Text Key338605171
Report Number3014334038-2024-00062
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,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number261221
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2024
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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