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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED HEX SCREWDRIVER BIT; STERILE DRIVER PIN
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TORNIER S.A.S. AEQUALIS REVERSED HEX SCREWDRIVER BIT; STERILE DRIVER PIN Back to Search Results
Catalog Number DWD167
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 12/03/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
 
Event or Problem Description
Very end of the screwdriver fused inside the glenospheres and sheered.It was not protruding and was not moving/able to be removed.5 minute delay as the surgeon tried to remove the end.The tip remained implanted.The surgeon was confident that it had fused into the glenoid sphere and would have caused damage if we attempted to get it out.
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
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Brand Name
AEQUALIS REVERSED HEX SCREWDRIVER BIT
Common Device Name
STERILE DRIVER PIN
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin, 38330
FR  38330
MDR Report Key8743892
Report Number3000931034-2019-00099
Device Sequence Number13873240
Product Code HXX
UDI-Device Identifier03700386943775
UDI-Public03700386943775
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/13/2019
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
Operator of Device No Information
Device Catalogue NumberDWD167
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/13/2019
Supplement Date Received by Manufacturer06/13/2019
Initial Report FDA Received Date06/28/2019
Supplement Report FDA Received Date10/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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