MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOCLIP; STAPLE

Catalog Number 1442-1814

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

This mdr was identified as part of complaint file remediation project.The doctor performed a surgery on (b)(6) 2017 and used a 18x14mm motoclip implant.Six (6) months post op the patient requested that the implant be removed and a revision surgery was performed.During the revision surgery, the doctor noticed the implant was loose and removed only the bridge.The clip legs remain in the patient.The doctor confirmed fusion by xray at the surgical site.The clip did not appear broken on the xray.No additional hardware was implanted during the revision surgery.Sem images confirmed a fatigue fracture likely while implanted as opposed to brittle fracture at removal.

Event Description

The doctor performed a surgery on (b)(6) 2017 and used a 18x14mm motoclip implant.Six (6) months post op the patient requested that the implant be removed and a revision surgery was performed.During the revision surgery, the doctor noticed the implant was loose and removed only the bridge.The clip legs remain in the patient.The doctor confirmed fusion by xray at the surgical site.The clip did not appear broken on the xray.No additional hardware was implanted during the revision surgery.

• Brand Name: MOTOCLIP
• Type of Device: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway ste 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 9406431
• MDR Text Key: 184533834
• Report Number: 3011421599-2019-00016
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00850310006106
• UDI-Public: 00850310006106
• Combination Product (y/n): N
• PMA/PMN Number: K142727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 1442-1814
• Device Lot Number: 1010687
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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 Outcome(s): Required Intervention