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

Model Number	3100-0030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximately, 2 weeks after the initial surgery , the patient fell and landed with her full weight on the foot with minibunion system.An x-ray after the fall was provided showing significant swelling.The patient was experiencing pain; therefore, the surgeon removed minibunion and replaced with 2 screws.The device was not broken.No defects or nonconformance that may lead to failure were identified.Additional implants involved in the incident include: ref: 3100-3022lk, ln: 500729, qty: 1, product name: 3.0x22 locking screw.Ref: 3100-2714nl, ln: 500719, qty: 1, product name: 2.9x14 non-locking screw.
Event or Problem Description
Approximately, 2 weeks after the initial surgery, the patient fell and landed with her full weight on the foot with minibunion system.An x-ray after the fall was provided showing significant swelling.The patient was experiencing pain; therefore, the surgeon removed the implant.

• Brand Name: MINIBUNION SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis, tn
• MDR Report Key: 9948454
• Report Number: 3011421599-2020-00008
• Device Sequence Number: 3423350
• Product Code: HRS
• UDI-Device Identifier: 00815432027149
• UDI-Public: 00815432027149
• Combination Product (Y/N): N
• PMA/510(K) Number: K190658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: 11/27/2021
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 500938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention