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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 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
This is 4 of 4 reports linked to mfg report numbers: 3014334038-2022-00092, 3014334038-2022-00093, and 3014334038-2022-00094.A facility reported a disposable perforator (id 261221) did not stop when it went through the bone and injured the dura.The event did not led to surgical delay.
 
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 - the perforator unit was inspected using the unaided eye.No anomalies were observed since the returned unit was a new sample, representative of the perforator used in surgery.Ifu testing procedure was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
Manufacturer Narrative
Root cause analysis - potential root cause includes 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 Key14399937
MDR Text Key291712955
Report Number3014334038-2022-00095
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 07/13/2022
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 Number5988967
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/27/2022
Initial Date FDA Received05/13/2022
Supplement Dates Manufacturer Received06/24/2022
Supplement Dates FDA Received07/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2022
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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