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

Model Number	7150-0018
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At routine follow-up the surgeon noted that the mpj plate was broken at the fusion site approximately 3 months after the initial surgery.The patient was non-weight bearing for 2 weeks then weight bearing for 8 weeks.The surgeon got a ct scan and determined fusion would not likely occur.The surgeon removed the device and place non-crossroads devices on (b)(6) 2020.The implant was removed without complication.Review of product records confirm all components conform to astm f136 ti-6al-4v titanium alloy.No nonconformance was identified.Additional components used in this case: 7118-1818kt, 300218, 18x18 himax staple with inst kit - sterile the staple was intact across the broken plate.
Event or Problem Description
At routine follow-up the surgeon noted that the mpj plate was broken at the fusion site approximately 3 months after the initial surgery.The patient was non-weight bearing for 2 weeks then weight bearing for 8 weeks.The surgeon got a ct scan and determined fusion would not likely occur.The surgeon removed the device without complication and place non-crossroads devices on (b)(6) 2020.

• Brand Name: MOTOBAND
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 11072281
• Report Number: 3011421599-2020-00016
• Device Sequence Number: 3260285
• Product Code: HRS
• UDI-Device Identifier: 00815432026364
• UDI-Public: 00815432026364
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/24/2020

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: 02/05/2022
• Device Model Number: 7150-0018
• Device Catalogue Number: 7150-0018
• Device Lot Number: 500991
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/24/2020
• 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