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

Catalog Number 7118-1818KT

Device Problem Fracture (1260)

Patient Problems Pain (1994); Swelling (2091)

Event Date 02/27/2019

Event Type  Injury  

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 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
• Type of Device: PLATE, CLIP, SCREWS
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway suite 140; memphis TN 38119
• Manufacturer Contact: vernon hartdegen ; 6055 primacy parkway; suite 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 8458320
• MDR Text Key: 140119370
• Report Number: 3011421599-2019-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00815432023288
• UDI-Public: 00815432023288
• Combination Product (y/n): N
• PMA/PMN Number: K173710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2018
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 72