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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
Catalog Number 261221
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
This is 3 of 6 reports linked to other mfg report number: 3014334038-2023-00071.3014334038-2023-00072.3014334038-2023-00074.3014334038-2023-00075.3014334038-2023-00076.A facility reported a codman perforator (id 261221) did not stop automatically.The product was in contact with the patient, however, no patient injury reported and the event did not led to surgical delay.The drill used was electric medtronic midas.The perforator clicked in place in the drill, and the recommended spring tests were being performed between each burr hole.The perpendicular approach was maintained through the drill process.There was a constant downward pressure.
 
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
The disposable perforator (id: 261221) 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: visual inspection utilizing unaided eye performed.The unit was lightly soiled and had a completely worn eo label.Spring test attempted: unit passed the spring test and functioned as designed.Functional test performed: unit successfully drilled 5 holes with no issues and functioned as designed.The complaint condition could not be confirmed.Unit passed all functional tests.Root cause: root cause remains undetermined.Product was received for analysis and the investigation could not confirm the complaint condition.The possible root cause per the failure analyst ¿drill allows to be set incorrectly¿ or ¿user misuse.¿.
 
Event Description
N/a.
 
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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 Key17097986
MDR Text Key317027550
Report Number3014334038-2023-00073
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 08/09/2023
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 Catalogue Number261221
Device Lot Number5823214
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/18/2023
Initial Date FDA Received06/09/2023
Supplement Dates Manufacturer Received07/25/2023
Supplement Dates FDA Received08/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2021
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
ELECTRIC MEDTRONIC MIDAS DRILL.
Patient SexMale
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