MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. REAMER; SMALL JOINT INSTRUMENT

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation not complete.Product has not been returned.Trends will be evaluated.This report will be updated when the investigation is complete.

Event Description

Allegedly, the tip of the reamer sheared off during a procedure.It was only discovered when post-surgery x-ray was taken.The clinical decision was made to leave the tip in the patient to prevent potential trauma to the joint.

• Brand Name: REAMER
• Type of Device: SMALL JOINT INSTRUMENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901867-414
• MDR Report Key: 5111842
• MDR Text Key: 27105550
• Report Number: 1043534-2015-00076
• 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
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1