MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS, LLC CROSSCLIP/MOTOCLIP IMPLANT SYSTEM; SINGLE/MULTIPLE COMPONETN METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES

Model Number 1442-2522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Surgeon provided 3 mo follow-up xrays.Xrays show fused joint.Clip leg appears to be fractured.Per surgeon, joint is properly fused and no revision surgery is planned or anticipated.Event has no adverse impact on patient at this time.Device return not expected.

Event Description

Patient age and weight unknown or not disclosed.Report of broken clip in fused joint - no revision surgery planned or anticipated.

• Brand Name: CROSSCLIP/MOTOCLIP IMPLANT SYSTEM
• Type of Device: SINGLE/MULTIPLE COMPONETN METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS, LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• Manufacturer (Section G): CROSSROADS EXTREMITY SYSTEMS, LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• Manufacturer Contact: vernon hartdegen ; 6055 primacy parkway; suite 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 6548514
• MDR Text Key: 74592608
• Report Number: 3011421599-2017-00003
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 0085031006120
• UDI-Public: (01)0085031006120(17)210101(10)101146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 1442-2522
• Device Catalogue Number: 1442-2522
• Device Lot Number: 101146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2016
• 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 Age: 55 YR
• Patient Weight: 45