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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; MODULAR HEAD TRIAL

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CORIN MEDICAL TRINITY; MODULAR HEAD TRIAL Back to Search Results
Model Number E922.336
Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Insufficient Information (3190); Device Fell (4014)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 08/01/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial report.Additional information, including a confirmation that the broken part of the device is available for return, if the device broke, if the device fell by accident due to incorrect handling, if the surgeon did anything unusual during the procedure has been requested in order to progress with the investigation of this event; and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have not been provided yet, therefore manufacturing records are yet to be located.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
 
Event Description
During surgery the trinity trial head fell off the broach neck and into the hip cavity.The surgeon could not locate the trial head by hand and was concerned about pushing it up further so decided to close the patient up and do an mri to locate the instrument and then surgically remove it later.This caused a 60 minute surgical delay.
 
Manufacturer Narrative
Per -4938 final report additional information including the return of both devices, photographs of the neck trials, device lot code & part number and an update on the patient post revision was requested.This information could not be provided and only the head trial was returned.The appropriate device details were provided for the head trial and the relevant device manufacturing and sterilisation records have been identified and reviewed.All parts associated with these records were cleaned, packaged and sterilised to the correct specifications at the time of manufacture.Testing on the head trial was unable to confirm or replicate the failure mode using the available neck trials in stock.Based on the available information, no further investigation can be conducted.The root cause of the incident is unknown as the neck trial has not been returned and no more information is available.This case is now considered closed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
 
Event Description
During surgery the trinity trial head fell off the broach neck and into the hip cavity.The surgeon could not locate the trial head by hand and was concerned about pushing it up further so decided to close the patient up and do an mri to locate the instrument and then surgically remove it later.This caused a 60 minute surgical delay.
 
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Brand Name
TRINITY
Type of Device
MODULAR HEAD TRIAL
Manufacturer (Section D)
CORIN MEDICAL
the corinium centre
cirencester, gloucestershire GL7 1 YJ
UK  GL7 1YJ
Manufacturer (Section G)
CORIN MEDICAL
the corinium centre
cirencester, gloucestershire GL7 1 YJ
UK   GL7 1YJ
Manufacturer Contact
dardan uka
the corinium centre
cirencester, gloucestershire GL7 1-YJ
UK   GL7 1YJ
MDR Report Key15197696
MDR Text Key298810383
Report Number9614209-2022-00070
Device Sequence Number1
Product Code LWJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K093472
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 11/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberE922.336
Device Catalogue NumberNOT APPLICABLE
Device Lot Number223892-04
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 08/03/2022
Initial Date FDA Received08/10/2022
Supplement Dates Manufacturer Received08/03/2022
Supplement Dates FDA Received11/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
TRIFIT TS NECK TRIAL - LOT & PART NO. NOT PROVIDED
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age43 YR
Patient SexMale
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