MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOCLIP; STAPLE

Catalog Number 1418-1818

Device Problems Activation, Positioning or Separation Problem (2906); Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was identified as part of complaint file remediation project.The doctor cut his hand on the leg of the inserter after the inserter broke during surgery.The doctor completed the facility's exposure control policy.The doctor is doing well and able to perform surgeries.The failure mode is a known risk of the device.Additional hardware used with the component previously listed: motoclip implant kit 18x18x18mm - sterile packaged part number 1418-1818; lot number 102001.

Event Description

The doctor cut his hand on the leg of the inserter after the inserter broke during surgery.The doctor completed the facility's exposure control policy.The doctor is doing well and able to perform surgeries.

• 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: 9410788
• MDR Text Key: 217329739
• Report Number: 3011421599-2019-00022
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00815432023158
• UDI-Public: 00815432023158
• Combination Product (y/n): N
• PMA/PMN Number: K142727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/03/2019

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
• Device Operator: No Information
• Device Catalogue Number: 1418-1818
• Device Lot Number: 101842
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2016
• 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