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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA; SHOULDER, PROSTHESIS, REVERSE CONFIGURATION
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TORNIER S.A.S. AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA; SHOULDER, PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Catalog Number DWD068
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2023
Event Type  malfunction  
Event Description
As reported: "inserting baseplate and the internal eyelet was rotating 180 degrees which was more than the expected variable angle.Pulled baseplate back out." update: the eyelet of the baseplate popped out while implanting.Later heard this is possible and can be popped back in.At the time didn¿t know so removed the whole baseplate and sent pi to examine.Another baseplate was used.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
As reported: "inserting baseplate and the internal eyelet was rotating 180 degrees which was more than the expected variable angle.Pulled baseplate back out." update: the eyelet of the baseplate popped out while implanting.Later heard this is possible and can be popped back in.At the time didn¿t know so removed the whole baseplate and sent pi to examine.Another baseplate was used.
 
Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.On the aequalis reversed baseplate in return, the two internal eyelets are not at the good location.So, they can rotate more than the expected variable angle.We can confirm that the eyelets were pulled back out of the baseplate.Two locking screws were inserted on the eyelets of the baseplate.During the screwing of the locking screws, the eyelets of the baseplate come back automatically in their initial position.At the end the screwing, they can¿t rotate more than the expected variable angle.The device is functional.A review of the labeling did not indicate any abnormalities.The operative technique provides in warning: "before fixing the multidirectional fixation screws, make sure that the baseplate¿s threaded rings have not moved after drilling the holes.This will help to avoid issue with final alignment of the screws.¿ on the additional feedback received from the customer, it¿s mentioned ¿later heard this is possible and can be popped back in.At the time didn¿t know so removed the whole baseplate.¿ based on investigation, the root cause was attributed to a user related issue.The event was caused by a learning gap errors.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
 
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Brand Name
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
Type of Device
SHOULDER, PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR  38330
Manufacturer (Section G)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR   38330
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key17864984
MDR Text Key325840364
Report Number3000931034-2023-00325
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K131231
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/05/2024
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 NumberDWD068
Device Lot Number6565AY
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2023
Initial Date FDA Received10/03/2023
Supplement Dates Manufacturer Received12/12/2023
Supplement Dates FDA Received01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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