MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS, LLC MOTOCLIP SUPERELASITIC FIXATION SYSTEM; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE/ BONE STAPLE

Model Number	1442-1814
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Recreation of failure was attempted in a simulated use.The surgery was an elective procedure at the request of the patient to remove the hardware; successful fusion was achieved.The broken staple leg was left in the patient.Based on investigation, our conclusion is that the staple leg broke upon removal.
Event or Problem Description
Patient requested removal of hardware after successful fusion.Joint was properly fused and patient is non-symptomatic.Elective surgery to remove hardware.At time of removal one leg of the staple broke during the removal process and was left in the patient.

• Brand Name: MOTOCLIP SUPERELASITIC FIXATION SYSTEM
• Common Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE/ BONE STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS, LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 6239640
• Report Number: 3011421599-2017-00001
• Device Sequence Number: 10861114
• Product Code: JDR
• UDI-Device Identifier: 00850310006106
• UDI-Public: (01)00850310006106(17)161216(10)101482
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2017

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: Physician
• Device Expiration Date: 12/16/2016
• Device Model Number: 1442-1814
• Device Catalogue Number: 1442-1814
• Device Lot Number: 101482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/10/2017
• 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: Other