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

Model Number	3100-0030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reports removal of the minibunion device approximately 2 months post-operatively.The 19- year-old female initial underwent the following during the initial operation on (b)(6) 2019: 1st metatarsal: right chevron and akin osteotomy for correction of hallux valgus.Placement of minibunion: 2nd metatarsal: crossover toe deformity correction, 3rd metatarsal: osteotomy and application of uniplanar external fixation, 4th metatarsal: osteotomy and application of uniplanar external fixation.The patient presented with wound breakdown and hardware exposure of the 3rd and 4th metatarsal uniplanar external fixation.The patient underwent surgery to remove the external fixation on (b)(6) 2020.During the surgery, the plate and screws (minibunion) was removed.The surgeon notes that the 1st metatarsal was well healed with solid fibrous union.No additional hardware was placed in the 1st metatarsal.
Additional Manufacturer Narrative
No non-conformances were identified in review of manufacturing records.Minibunion screws were removed in addition to the plate: ref: 3100-3020lk ln: 500728 qty: 1 product name: 20mm x 30mm locking screw ref: 3100-2714nl ln: 500719 qty: 1 product name: 14mm x 2.7mm non-locking screw.

• Brand Name: MINIBUNION
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view drive; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15501555
• Report Number: 3020584246-2022-00051
• Device Sequence Number: 5212550
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 02/09/2021
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 300167
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• 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: 18 YR
• Patient Sex: Female