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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS
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RAYNHAM CODMAN DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number XXX-CODMAN PERFORATOR
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 the perforator got stuck due to patient's thick skull.An additional drill bit was needed to drill out the perforator bit.An anspach pneumatic drill was used, and the perforator click into place in the drill.No patient injury reported.Surgical delay was reported due to product issue; unknown for how long.
 
Event Description
N/a.
 
Manufacturer Narrative
Udi: (b)(4) or (b)(4).A dhr review could not be completed because the lot number was not reported and not legible on the returned product label.Failure analysis: the perforator unit was inspected using the unaided eye.The unit was heavily soiled from surgery, had visible tool marks on the sleeve.Label was destroyed and could not be read.Ifu testing was performed.The inner and outer sleeves were fused, likely due to organic material and were not easily freed.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.When engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.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.It is noted that it took two drilled holes to free the inner and outer drill, and once freed the remaining holes were drilled as intended.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA
MDR Report Key11510113
MDR Text Key245328143
Report Number3014334038-2021-00047
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberXXX-CODMAN PERFORATOR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2021
Date Manufacturer Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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