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

Model Number 3100-0030

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 01/29/2020

Event Type  malfunction  

Event 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.

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
• 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 drive; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15501555
• MDR Text Key: 302403346
• Report Number: 3020584246-2022-00051
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2021
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 300167
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• 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): Other
• Patient Age: 18 YR
• Patient Sex: Female