MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. XMCP; REAMER

Catalog Number 120-01000

Device Problem Fracture (1260)

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

Event Date 11/07/2018

Event Type  malfunction  

Event Description

During a surgical procedure, the xmcp reamer began to twist and break at the distal tip.

• Brand Name: XMCP
• Type of Device: REAMER
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; suite 410; parsippany NJ 07054
• Manufacturer Contact: brian smekal ; 300 interpace parkway; suite 410; parsippany, NJ 07054 ; 9735888980
• MDR Report Key: 8161956
• MDR Text Key: 130481237
• Report Number: 3007289093-2018-00033
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2018

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: No Information
• Device Catalogue Number: 120-01000
• Device Lot Number: 3327501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1