MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE GLENOID TRAY

Catalog Number 321-41-01

Device Problems Break (1069); No Apparent Adverse Event (3189)

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

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

Wrap on instrument tray damaged prior to surgery, the case was cancelled.There were no adverse events to patient.

Manufacturer Narrative

Section h3: the complaint product was not received for analysis.The user experience of the drape being torn is difficult to conclude what exactly tore the drape and what makes it difficult to wrap.The frequency of occurrence ranking scale is very low; however, this issue may be related to the design of the clasps that hold the lids onto the cases or the rivets that hold the plastic dividers in place on the lower rack of the tray and protrude through the tray underside.Manufacturing information could not be reviewed because the lot/serial information was not provided.In reviewing risk management documentation for modular instrument cases, there is a hazard identified as: "instrument case tears sterile wrap." this potential risk is mitigated through a fit and function evaluation.This case design consists of several separate components that can be assembled in different configurations.This tray is a sub assembly to a larger construct and is not intended to be sterile wrapped outside of the larger case configuration.The issue reported may have been the result of either the clasps that hold the lid onto the case coming undone and puncturing the drape, or the rivets protruding through the bottom of the tray and cutting through the drape following processing at the hospital.Or it could have been caused by handling by the hospital staff.Section h6: in review of the labeling, it is stated to clean the instruments as the labeling states, in accordance with all local policies, and instructions of the solution manufacturers within the instruments intended use.Useful life is normally determined by visual and/or functional evaluation prior to use.It is a known procedure in the operating room that all packages/instruments/devices should be inspected before opening/use.This device is used for treatment not diagnosis.No information, asked not provided.Section(s): no information a2-6, no patient involvement.

Event Description

It was reported from the united kingdom, there was an issue with an instrument tray."due to design of the tray, it is difficult to wrap, which led to a torn drape.No injuries occurred, but the case had to be cancelled." the tray was placed back into circulation by the hospital.No additional information has been provided about the event.

• Brand Name: EQUINOXE REVERSE GLENOID TRAY
• Type of Device: GLENOID TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7672900
• MDR Text Key: 113755257
• Report Number: 1038671-2018-00547
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321-41-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other