MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MINIBUNION; PLATE, FIXATION, BONE

Model Number 3100-0030

Device Problems Deformation Due to Compressive Stress (2889); Patient Device Interaction Problem (4001)

Patient Problem Fall (1848)

Event Date 04/14/2022

Event Type  malfunction  

Event Description

The original implant date was (b)(6) 2022 for the minibunion plates and screws.On (b)(6) 2022, revision surgery occurred.The reporter states that the patient fell off a scooter causing the capital fragment to shift and misalign.The surgeon completed revision surgery replacing both screws leaving the initial minibunion plate.

Manufacturer Narrative

The original implant date was (b)(6) 2022 for the minibunion plates and screws.On (b)(6) 2022, revision surgery occurred.The reporter states that the patient fell off a scooter causing the capital fragment to shift and misalign.The surgeon completed revision surgery replacing both screws leaving the initial minibunion plate.The following screws were removed with the plate: ref: 3100-3020lk, ln: 501616, qty: 1, product name: minibunion locking screw 3.0mm x 20mm, ref: 3100-2714nl, ln: 501559, qty: 1, product name: minibunion non-locking screw 2.7mm x 14mm.

• Brand Name: MINIBUNION
• Type of Device: PLATE, 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: 15253176
• MDR Text Key: 305353770
• Report Number: 3020584246-2022-00003
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00815432027149
• UDI-Public: 00815432027149
• Combination Product (y/n): N
• PMA/PMN Number: K190658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 501604
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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): Required Intervention
• Patient Sex: Prefer Not To Disclose