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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS TRIMAX 18MM PREP KIT; STAPLE, FIXATION, BONE
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CROSSROADS EXTREMITY SYSTEMS TRIMAX 18MM PREP KIT; STAPLE, FIXATION, BONE Back to Search Results
Model Number TriMAX 18mm Prep Kit
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/21/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
While performing 1st metatarsal tmt fusion preparing for keel-lock implant, the cuneiform fractured.A dynaforce lapidus lz beta plate, 3 locking screws and 1 non-locking screw were used instead of the keel-lock implant for fusion and repaired the cuneiform.Part number 7318-1818, lot number 500917, 18x18x18 trimax implant.
 
Event or Problem Description
While performing 1st metatarsal tmt fusion preparing for keel-lock implant, the cuneiform fractured.A dynaforce lapidus lz beta plate, 3 locking screws and 1 non-locking screw were used instead of the keel-lock implant for fusion and repaired the cuneiform.
 
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Brand Name
TRIMAX 18MM PREP KIT
Common Device Name
STAPLE, FIXATION, BONE
Manufacturer (Section D)
CROSSROADS EXTREMITY SYSTEMS
6055 primacy parkway ste 140
memphis, tn
MDR Report Key9756846
Report Number3011421599-2020-00003
Device Sequence Number3308014
Product Code JDR
UDI-Device Identifier00815432027569
UDI-Public00815432027569
Combination Product (Y/N)N
PMA/510(K) Number
K191342
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/21/2020
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 Expiration Date11/04/2021
Device Model NumberTriMAX 18mm Prep Kit
Device Catalogue Number7300-1800KT
Device Lot Number500917
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/21/2020
Initial Report FDA Received Date02/26/2020
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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