MAUDE Adverse Event Report: TOURNIER, INC. TOURNIER AEQUALIS PERFORM GLENOID SYSTEM REAMER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number MWE151-20C805

Device Problems Contamination (1120); Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

Tournier surgical instrument company representative delivered five cannulated instruments with extensive debris and residue inside the channels.Residue appeared to be rust, chemical residue, possible bioburden.The instruments were loaner instruments delivered by the milwaukee wisconsin area rep for tournier.The five instruments, which were cannulated drill/reamer drivers, were part of the aequalis perform glenoid system.Part numbers were mwe152-20c291, mwe151-18c354; mwe152-17c311; mwe151-20c805; mwe151-21c465 attached photo was taken inside the instrument with a borescope system, and is similar to the photos of the other five reamers.Fda safety report id# (b)(4).

• Brand Name: TOURNIER AEQUALIS PERFORM GLENOID SYSTEM REAMER
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TOURNIER, INC.
• MDR Report Key: 15210270
• MDR Text Key: 297795145
• Report Number: MW5111420
• Device Sequence Number: 3
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MWE151-20C805
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1