MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS TRIMAX; KEEL LOCK

Model Number 7300-1800KT

Device Problems Fracture (1260); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2020

Event Type  malfunction  

Event Description

The surgeon performed an isolated tn fusion on (b)(6) 2020.The patient was fused, and devices were intact at 60 days post-op.At 85 days post-op, the x-ray reveals that the keel on the keel-lock staple has broken and the staple has backed out of the bone.The patient was weight-bearing in a cam boot 1 week prior to observation of the broken staple.Fusion remains intact despite the back-out of the staple.

Manufacturer Narrative

The lot history records of the sterile and individual component parts were reviewed in their entirety during the investigation.These records included quality inspection records, component inspection records, component print specification, component supplier certificates of conformance, supplier inspection certificates, raw material certificates of conformance, and supplier certificates of conformance.No non-conformances were found in any records that were reviewed that would have contributed to the device failure.7318-1818 500917, keel-lock staple, 240509-ep, 103968, keel-lock staple - component; 7300-1800kt, 104074, keel-lock staple prep kit; 248501, 103573, trimax drill guide 18mm; 246002, 103678, instrument, dynaforce reamer.

• Brand Name: TRIMAX
• Type of Device: KEEL LOCK
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15501549
• MDR Text Key: 304964136
• Report Number: 3020584246-2022-00044
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00815432027590
• UDI-Public: 00815432027590
• Combination Product (y/n): N
• PMA/PMN Number: K190722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: 7300-1800KT
• Device Catalogue Number: 7300-1800KT
• Device Lot Number: 104074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2019
• 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