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

Model Number	3100-0030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor communicated that the doctor had 3 potential infections occurred with minibunion usage.The surgeon confirmed that one of cases performed on (b)(6) 2020 experienced delayed healing, edema and took oral antibiotics.The surgeon expressed that during the procedure control of the capital fragment was difficult and the bone cortex may not have been smooth causing soft tissue irritation as there is not a lot of tissue over the surgical site.The hardware was not removed, and healing occurred approximately 6 weeks post-operatively.The part number and lot number associated with the event is unknown.The surgeon performed 4 cases; 3 cases included a single lot.Part number 3100-2716nl lot 510023 with available parts.Cytotoxicity, endotoxin and bioburden testing was performed and met acceptance criteria.Additional part numbers implanted include: 3100-2716nl lot 501079 minibunion 2.7x16mm non-locking screw.3100-3022lk lot 501197 minibunion 3.0x22mm locking screw.
Event or Problem Description
The distributor communicated that the doctor had 3 potential infections occurred with minibunion usage.The surgeon confirmed that one of cases performed on (b)(6) 2020 experienced delayed healing, edema and took oral antibiotics.The surgeon expressed that during the procedure control of the capital fragment was difficult and the bone cortex may not have been smooth causing soft tissue irritation as there is not a lot of tissue over the surgical site.The hardware was not removed, and healing occurred approximately 6 weeks post-operatively.

• Brand Name: MINIBUNION
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 11730319
• Report Number: 3011421599-2021-00004
• Device Sequence Number: 3832617
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 10/13/2022
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 501263
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 04/27/2021
• 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