MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS TRIMAX 18MM PREP KIT; STAPLE, FIXATION, BONE

Model Number TriMAX 18mm Prep Kit

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 02/21/2020

Event Type  malfunction  

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 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.

• Brand Name: TRIMAX 18MM PREP KIT
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis, tn
• Manufacturer Contact: 6055 primacy parkway ste 140; memphis, tn ; 2218406
• MDR Report Key: 9756846
• MDR Text Key: 199076105
• Report Number: 3011421599-2020-00003
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00815432027569
• UDI-Public: 00815432027569
• Combination Product (y/n): N
• PMA/PMN Number: K191342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Expiration Date: 11/04/2021
• Device Model Number: TriMAX 18mm Prep Kit
• Device Catalogue Number: 7300-1800KT
• Device Lot Number: 500917
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other