MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOCLIP; STAPLE

Catalog Number	1418-1818
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was identified as part of complaint file remediation project.The doctor implanted an 18x18mm motoclip implant and a motoband 4 hole plate on (b)(6) 2017.During routine follow up visits, the doctor noticed that the fusion site was experiencing a delayed union.A bone stimulator was used to promote fusion.During additional follow up visits, the doctor noticed that the fusion site appeared to have experienced proper fusion.The doctor instructed the patient to start weight bearing.Another follow up visit revealed that one of the plate screws had backed out of the plate and the motoclip implant had mechanically fractured in one of the legs.The broken hardware was symptomatic and causing irritation for the patient.The doctor performed a revision surgery in order to remove the broken hardware.Due to the sufficient fusion present at the site, the doctor did not implant additional hardware once the initial hardware was explanted.The size and lot of the screw that backed out are unknown.No defects were found with the crossroads motoclip or motoband implants that were used.The device failure category is currently unknown and potentially related to weight-bearing prior to fusion.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: motoband 4-hole straight plate part number 1500-0005 lot number 101692 screw part number and lot number unknown.
Event or Problem Description
At a follow up visit imaging revealed that one of the plate screws had backed out of the plate and the motoclip implant had mechanically fractured in one of the legs.The broken hardware was symptomatic and causing irritation for the patient.The doctor performed a revision surgery in order to remove the broken hardware.

• Brand Name: MOTOCLIP
• Common Device Name: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 9406453
• Report Number: 3011421599-2019-00017
• Device Sequence Number: 2167499
• Product Code: JDR
• UDI-Device Identifier: 00815432023158
• UDI-Public: 00815432023158
• Combination Product (Y/N): N
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: 1418-1818
• Device Lot Number: 102001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/03/2019
• 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