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

Catalog Number	3100-2716NL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Missing Value Reason (3192)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The doctor performed a minibunion surgery on (b)(6) 2019.At 2nd week follow-up the patient was walking, and the incision opened up resulting in wound issues.The doctor washed the incision on (b)(6) 2019 and tightened the non-locking screw.The shaft was packed with cancellous bone chips.The patient was hospitalized for 7 days.Intravenous antibiotics were given for 2 weeks and oral antibiotics for an additional 2 weeks.No evidence of a bone infection was identified.No device defects were identified in the investigation.Potentially, early patient mobility may lead to screw back-out.Component implants used in entire construct: minibunion non-locking screw 2.7mm x 16mm part number: 3100-2716nl, lot number: 500720.Minibunion 3.5mm offset plate short part number: 3100-0030, lot number: 500737.Minibunion locking screw 3.0mm x 18mm part number: 3100-3018lk, lot number: 500727.
Event or Problem Description
The doctor performed a minibunion surgery on (b)(6) 2019.At 2nd week follow-up the patient was walking, and the incision opened up resulting in wound issues.The doctor washed the incision on (b)(6) 2019 and tightened the non-locking screw.The shaft was packed with cancellous bone chips.The patient was hospitalized for 7 days.Intravenous antibiotics were given for 2 weeks and oral antibiotics for an additional 2 weeks.No evidence of a bone infection was identified.

• 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: 9460299
• Report Number: 3011421599-2019-00027
• Device Sequence Number: 14221148
• Product Code: HRS
• UDI-Device Identifier: 00815432027026
• UDI-Public: 00815432027026
• Combination Product (Y/N): N
• PMA/510(K) Number: K190658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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 Catalogue Number: 3100-2716NL
• Device Lot Number: 500720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/12/2019
• 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: Hospitalization; Required Intervention