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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

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RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Model Number 261221
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem Brain Injury (2219)
Event Date 04/06/2023
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 disposable perforator (id 261221) did not disengage when penetrating the bone and perforated the dura.The manufacturer of the drill used with the perforator was pneumatic medtronic drill.The perforator clicked in place in the drill, and the recommended spring tests were being performed between each burr hole.The angle of approach was perpendicular as the ifu states and maintained with no rocking motion.There was constant downward pressure.The patient was fine without major issues resulting from this incident.
 
Event Description
N/a.
 
Manufacturer Narrative
The codman perforator (id (b)(4)) was returned for evaluation.Device history record (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 utilizing unaided eye was performed.The unit was lightly soiled with organic material but showed no other anomalies.A spring test was performed.Unit passed as designed with no issues.The functional test was performed: the unit successfully drilled 5 holes with no issues.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)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key16806878
MDR Text Key313918269
Report Number3014334038-2023-00055
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 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? No
Device Operator Health Professional
Device Model Number261221
Device Catalogue Number261221
Device Lot Number6398970
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/06/2023
Initial Date FDA Received04/25/2023
Supplement Dates Manufacturer Received06/23/2023
Supplement Dates FDA Received07/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
PNEUMATIC MEDTRONIC DRILL
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