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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RTI SURGICAL SLIMFUSE; HOLLOWED DRIVER
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RTI SURGICAL SLIMFUSE; HOLLOWED DRIVER Back to Search Results
Model Number 21-CANDRIVER
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/26/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A device history review was done and the device met all specifications.This is report 2 of 5.Several attempts have been made to get the device back for inspections and it still has not been returned.
 
Event or Problem Description
During a slimfuse removal case, the set screws stripped.The surgeon made several attempts to remove the screws and broke mutilple devices.All pieces were retrieved and there was a surgical delay of 40 minutes and no patient effect.
 
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Brand Name
SLIMFUSE
Common Device Name
HOLLOWED DRIVER
Manufacturer (Section D)
RTI SURGICAL
375 river park circle
marquette MI 49855
MDR Report Key7541567
Report Number1833824-2018-00013
Device Sequence Number16502030
Product Code KWQ
UDI-Device Identifier00846468062675
UDI-Public(01)00846468062675(10)172524
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
K072703
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/24/2018
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 Physician
Device Model Number21-CANDRIVER
Device Catalogue NumberSAME
Device Lot Number172524
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/26/2018
Initial Report FDA Received Date05/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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