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

Model Number	1443-2510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor was having trouble getting the implant to release from the old inserter because it was really tight.Once the doctor was finally able to release the implant, the implant broke in the process.The doctor then opened another crosstie kit and began to insert the implant.While he was inserting the implant, the doctor noticed a crack in the cortex.Once the doctor had noticed that the cortex was cracked, he decided to use a k-wire instead of a crosstie.He did not directly address the crack that occurred.Other crosstie implants were successfully implanted by this doc during this procedure.
Additional Manufacturer Narrative
The difficulty to release the implant from this inserter is related to the design of this particular inserter.To address the tightness of this design, a new universal inserter was designed and released.We have users of both styles of inserters.Based on previous investigations, excessive force is required to break the implant during insertion.At the point that the doctor was having difficulty releasing the implant, instead of using excessive force while attempting to release the implant, either a new kit should have been opened or an attempt should have been made to release the implant outside of the patient and reload the implant for easier release.Part was not returned.X-rays were not received to confirm that the bone was fractured or that a k-wire was used.

• 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: 15501740
• Report Number: 3020584246-2022-00008
• Device Sequence Number: 8133825
• Product Code: HWC
• UDI-Device Identifier: 00850310006533
• UDI-Public: 00850310006533
• 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 Model Number: 1443-2510
• Device Lot Number: 101684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2016
• 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