MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, CLIP, SCREWS

Catalog Number	7118-1818KT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nitinol clip listed previously was used in conjunction with the implants listed below as a total construct for bone fragment osteotomy fixation and joint arthrodesis.In addition to the pain and swelling from the patient, the nitinol implant and the locking screw listed below experienced mechanical failure at some time post-operation.Component implants used in entire construct: motoband cp - locking screws - 3.0mm x 16mm, catalog#: 1500-3016, lot#: 500079, expiration: 08/01/2022.Motoband cp - non-locking screws - 3.5mm x 22mm, catalog#: 1500-3522, lot#: 101416, expiration: 04/01/2021.Dynaforce motoband max z-beta plate 18mm, catalog#: 7100-zb18, lot#: 500243, expiration: 03/15/2020.
Event or Problem Description
Lapidus procedure was performed on (b)(6) 2018.In follow-up, doctor reports partial fusion of joint in additional to breakage of the hardware - namely 1 locking screw and 1 leg of a nitinol clip.Patient has post-operation pain and swelling.Revision surgery was performed on (b)(6) 2019 to remove hardware.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: PLATE, CLIP, SCREWS
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway suite 140; memphis TN 38119
• MDR Report Key: 8458320
• Report Number: 3011421599-2019-00001
• Device Sequence Number: 429221
• Product Code: HRS
• UDI-Device Identifier: 00815432023288
• UDI-Public: 00815432023288
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: 7118-1818KT
• Device Lot Number: 103010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/27/2019
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 72