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	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the surgeon removed the metatarsal head screw, repositioned the metatarsal head due to plantarflexion and placed the same screw.The original implant was placed (b)(6) 2020.The revision was performed on (b)(6) 2020.The surgeon concluded that the plantarflexion was due to intraoperative correction deficiency due to lateral x-ray view.The surgeon will move the fluro machine in the future as opposed to moving the foot to get a true lateral view peri-operatively to ensure proper alignment.Additional implants involved in the incident include: ref: (b)(4), ln: 500721, qty: 1, product name: minibunion non-locking screw 2.7mm x 18mm, ref: (b)(4), ln: 501075, qty: 1, product name: minibunion locking screw3.0mm x 20mm.
Event or Problem Description
It was reported that the surgeon removed the metatarsal head screw, repositioned the metatarsal head due to plantarflexion and placed the same screw.The original implant was placed (b)(6) 2020.The revision was performed on (b)(6) 2020.

• 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: 10469764
• Report Number: 3011421599-2020-00013
• Device Sequence Number: 19717357
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2020

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: No Information
• Device Expiration Date: 03/06/2022
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 501029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/30/2020
• 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
• Patient Age: 47 YR