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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLARIANCE SAS ERISMA LP SCREWDRIVER

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CLARIANCE SAS ERISMA LP SCREWDRIVER Back to Search Results
Model Number 18911039
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/20/2019
Event Type  Injury  
Manufacturer Narrative
For this adverse event, as the incriminated device has not been received yet, clariance (b)(4) is unable to do any analysis for the moment. No additional information are available. Clariance will go forward on the investigation when the instrument is received.
 
Event Description
Screwdriver tip broke off inside the screw head. Sheared off cleanly so surgeon left the sheared fragment in place and locked rod down overtop of it.
 
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Brand NameERISMA LP
Type of DeviceSCREWDRIVER
Manufacturer (Section D)
CLARIANCE SAS
18, rue robespierre
beaurains, 62217
FR 62217
Manufacturer (Section G)
CLARIANCE SAS
18, rue robespierre
beaurains, 62217
FR 62217
Manufacturer Contact
ms bahr
18, rue robespierre
beaurains, 62217
FR   62217
MDR Report Key9291175
MDR Text Key165563981
Report Number3008992889-2019-00002
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number18911039
Device Catalogue Number18911039
Device Lot NumberH224X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/07/2019 Patient Sequence Number: 1
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