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

Model Number	7318-1818
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
At routine follow-up, a fractured keel-lock staple leg was identified in the follow-up x-ray.Tn fusion has occurred, and the patient is asymptomatic.The surgeon does not plan to revise the patient.
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 18mm x 18 mm x 18mm sterile.240509-ep.103968.Keel-lock 18mm x 18 mm x 18mm.

• Brand Name: CROSSTIE
• 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: 15501692
• Report Number: 3020584246-2022-00048
• Device Sequence Number: 7755397
• Product Code: HRS
• UDI-Device Identifier: 00815432027736
• UDI-Public: 00815432027736
• 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: 11/04/2021
• Device Model Number: 7318-1818
• Device Catalogue Number: 7318-1818
• Device Lot Number: 500917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2019
• 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 Age: 43 YR
• Patient Sex: Female