MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS CROSSTIE INTRAOSSEOUS FIXATION SYSTEM; SCREW, FIXATION, BONE

Model Number	1444-2500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A crosstie implant was broken while trying to insert the implant.A crosstie universal inserter was used to insert the subject implant.
Additional Manufacturer Narrative
A crosstie implant was broken while trying to insert the implant.A crosstie universal inserter was used to insert the subject implant.Another corsstie kit was successfully used.Failure most likely caused by excessive shear force while trying to insert the implant.No evidence was found that the implant did not meet specifications prior to distribution.

• Brand Name: CROSSTIE INTRAOSSEOUS FIXATION SYSTEM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 15501478
• Report Number: 3020584246-2022-00006
• Device Sequence Number: 8133819
• Product Code: HWC
• UDI-Device Identifier: 00850310006540
• UDI-Public: 00850310006540
• Combination Product (Y/N): N
• PMA/510(K) Number: K151270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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: 06/30/2020
• Device Model Number: 1444-2500
• Device Catalogue Number: 1444-2500
• Device Lot Number: 100944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2015
• 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: 61 YR
• Patient Sex: Female