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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 Fragmentation (1261)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 12/19/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
 
Event or Problem Description
Tip of driver broke while screwing in the baseplate.The tip is still inside patient.
 
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 Key8253207
Report Number3000931034-2019-00013
Device Sequence Number1439877
Product Code HXX
UDI-Device Identifier03700386943775
UDI-Public03700386943775
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
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
Operator of Device Health Professional
Device Expiration Date05/06/2023
Device Catalogue NumberDWD167
Device Lot Number6950AT
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 12/20/2018
Supplement Date Received by Manufacturer12/20/2018
Initial Report FDA Received Date01/16/2019
Supplement Report FDA Received Date04/19/2019
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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