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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID AND REVERSED PIN SURGICAL ORTHOPEDIC INSTRUMENT

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TORNIER S.A.S. AEQUALIS GLENOID AND REVERSED PIN SURGICAL ORTHOPEDIC INSTRUMENT Back to Search Results
Model Number DIAM.2.5 MM LENGTH 200MM
Device Problem Material Fragmentation (1261)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/05/2018
Event Type  Injury  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event Description
Tip of threaded pin snapped off inside patient's glenoid. No impact to patient. The tip was removed under x-ray. (additional surgical procedure required).
 
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Brand NameAEQUALIS GLENOID AND REVERSED PIN
Type of DeviceSURGICAL ORTHOPEDIC INSTRUMENT
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin, 38330
FR 38330
Manufacturer Contact
maud andriollo
161 rue lavoisier
montbonnot saint-martin, 38330
FR   38330
MDR Report Key8207829
MDR Text Key131768690
Report Number3000931034-2019-00004
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDIAM.2.5 MM LENGTH 200MM
Device Catalogue NumberDWD063
Device Lot Number4281AT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/02/2019 Patient Sequence Number: 1
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