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

Model Number 1443-2511

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

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

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

The reporter states that the surgeon implanted a 2.5 crosstie, part number 1443-2511 lot number 105448.The surgeon implanted it and was going to begin suture and grabbed the toe and the implant broke in half.The surgeon pulled one out and the other end was drilled out.Removal and reimplant was about 4 minutes long.An alternate implant was placed with minimal surgical delay.No non-conformances were identified in the investigation.The root cause is that the crosstie implant is a small diameter implant with potential to fracture if over-stressed.

Event Description

The reporter states that the surgeon implanted a 2.5 crosstie, part number 1443-2511 lot number 105448.The surgeon implanted it and was going to begin suture and grabbed the toe and the implant broke in half.The surgeon pulled one out and the other end was drilled out.Removal and reimplant was about 4 minutes long.An alternate implant was placed with minimal surgical delay.

• Brand Name: CROSSTIE INTRAOSSEOUS FIXATION SYSTEM
• Type of Device: 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: 15501822
• MDR Text Key: 306342106
• Report Number: 3020584246-2022-00056
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00815432022052
• UDI-Public: 00815432022052
• Combination Product (y/n): N
• PMA/PMN Number: K151270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2022

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 Model Number: 1443-2511
• Device Catalogue Number: 105448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 59 YR
• Patient Sex: Male