MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS, LLC CROSSCLIP/MOTOCLIP IMPLANT SYSTEM; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE ADN ACCESSORIES

Model Number	1412-1212
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Surgeon provided 3 month follow-up xray that indicates non union of the first distal phalangeal joint.Two 12mm clips were used in the initial surgery.Based on xray review one, possibly both clips are broken in the bridge/shoulder area.Surgeon indicated potential patient non compliance may have contributed to event.Revision surgery is expected, but no revision surgery date has been provided.Based on investigation by company, there is no evidence to suggest device is out of specification.Based on investigation and patient variables no conclusion can be made at this time.Devices not returned.
Event or Problem Description
Patient age is unknown or not disclosed.Surgeon provided 3 month xray that shows a non union of the first distal plangeal joint.Joint was initially fixated with two clips.One or both clips appear to be broken revision surgery is expected, but no date provided.

• Brand Name: CROSSCLIP/MOTOCLIP IMPLANT SYSTEM
• Common Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE ADN ACCESSORIES
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS, LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 6548540
• Report Number: 3011421599-2017-00002
• Device Sequence Number: 11015463
• Product Code: JDR
• UDI-Device Identifier: 00815432023127
• UDI-Public: (01)00815432023127(17)180627(10)101491
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2017

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: 06/27/2018
• Device Model Number: 1412-1212
• Device Catalogue Number: 1412-1212
• Device Lot Number: 101491
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 05/05/2017
• 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: Required Intervention
• Patient Age: 55 YR