MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE, 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	GLENOSPHERE, 36MM
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, prior to use and during set-up, while the nurse was opening the sterile packaging, they noticed a hair inside the package.The physician had to grab and open another glenosphere.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The device is available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(h3): the hair within sterile packaging reported was likely the result of a lack of standardization around variables (process, lighting, ppe) pertaining to material handling and visual inspection.Variance in applied ppe of red/blue zones, lack of operator awareness during visual inspection, inconsistency in red zone disinfection frequency, and interim product storage/cleaning are areas of concern that contributed to hair and fod in the sterile barrier system.Additionally, a lack of routine training decreased awareness around contamination complaints historically investigated, contributed to field contamination complaints of pouch sealed product.

• Brand Name: GLENOSPHERE, 36MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19570616
• Report Number: 1038671-2024-02014
• Device Sequence Number: 15228131
• Product Code: PHX
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: GLENOSPHERE, 36MM
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 07/15/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/17/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown