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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 Fail-Safe Did Not Operate (4046)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 04/04/2023
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 perforator plunged, not cutting out as it reaches the end of the burr hole.The event caused significant bleeding which was brought under control.
 
Manufacturer Narrative
Additional information received: date of event : april 4th 2023.Product id : 261221.Lot number : 6957549.Device was found unacceptable.Nature of the event: "when using the perforator to gain access to the tumor, it did not disengage allowing to recoil as its supposed to when not on bone and continued to drill.This caused a venous bleed and also the patient to have a temporary cranioplasty made by radiopaque bone cement.".Did the event lead to increase surgery time? if yes for how long (less or more than 30 minutes) - answer : 20 mins how did the medical staff finish the procedure? answer : continued as planned after homeostasis where was the exact location of the 1st burr hole on the frontal side of the skull? left frontal 1cm lateral to midline how much bleeding was observed? 500-750ml how was hemostasis achieved? (e.G.Manual pressure, hemostatic agents, cautery, etc.) - pressure, heamostatis, time was administration of blood products necessary? no what is the healing status of the patient? normal is the patient an adult, a child or a baby? adult was the angle of approach perpendicular as the ifu states? yes was the perpendicular approach maintained through the drilling process or was there any rocking motion included? perpendicular was there constant downward pressure? yes what is the manufacturer of the drill used with the perforator? medtronic was the drill electric or pneumatic? electric did the perforator click in place in the drill? yes are the recommended spring tests being performed between each burr hole? yes.
 
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 - a visual inspection performed noted that the unit was soiled with organic material, but no other anomalies were observed.A functional spring test was performed and its noted that the unit had a frozen inner/outer drill likely from the organic material present.Once the unit was cleaned, 5 test holes were drilled and the inner / outer drills were freed, moving as designed.Once freed the unit passed the spring test.After unit was freed a function test was performed and drilled 5 additional holes with no issue and functioned as designed.Therefore, the complaint condition could not be confirmed.Root cause - product was received for analysis and the analyst could not confirm the complaint condition.Root cause remains undetermined.Possible root cause per the failure analyst ¿user misuse or drill allows to be set incorrectly.¿.
 
Event Description
N/a.
 
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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 Key16860902
MDR Text Key314468640
Report Number3014334038-2023-00063
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,Followup
Report Date 08/02/2023
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? No
Device Operator Health Professional
Device Catalogue Number261221
Device Lot Number6957549
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/19/2023
Initial Date FDA Received05/03/2023
Supplement Dates Manufacturer Received05/03/2023
07/13/2023
Supplement Dates FDA Received06/02/2023
08/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2023
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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