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

Model Number	1443-2511
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: 15501822
• Report Number: 3020584246-2022-00056
• Device Sequence Number: 12065242
• Product Code: HWC
• UDI-Device Identifier: 00815432022052
• UDI-Public: 00815432022052
• Combination Product (Y/N): N
• PMA/510(K) Number: K151270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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: 06/02/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 59 YR
• Patient Sex: Male