MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; SCREW

Model Number	MotoBAND CP, Non-Locking Screw, 3mm x 24mm - Sterile
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reports that the screw broke during implantation.The screw was driven with the ratchet handle, not under power, and broke as it got to the plate.The surgeon removed the screw and plate and placed 2 staples for fusion instead.No surgical delay was reported.
Additional Manufacturer Narrative
The sales representative reports that the screw broke during implantation.The screw was driven with the ratchet handle, not under power, and broke as it got to the plate.The surgeon removed the screw and plate and placed 2 staples for fusion instead.No surgical delay was reported.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: SCREW
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr.; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15501820
• Report Number: 3020584246-2022-00050
• Device Sequence Number: 5212559
• Product Code: HWC
• UDI-Device Identifier: 00815432025435
• UDI-Public: 00815432025435
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 08/30/2021
• Device Model Number: MotoBAND CP, Non-Locking Screw, 3mm x 24mm - Sterile
• Device Catalogue Number: 15NL-3024
• Device Lot Number: 400037
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2019
• 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: 53 YR
• Patient Sex: Female