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

Model Number	7300-1800KT
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3020584246-2022-00044
• Device Sequence Number: 7848949
• Product Code: JDR
• UDI-Device Identifier: 00815432027590
• UDI-Public: 00815432027590
• Combination Product (Y/N): N
• PMA/510(K) Number: K190722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown