GLENOSPHERE, 36MM

Report

Report Number: 1038671-2024-02014
Event Type: Injury
Date Received: June 19, 2024
Date of Event: May 20, 2024
Report Date: September 10, 2024
Manufacturer: EXACTECH, INC.
Product Code: PHX
UDI-DI: 10885862534934
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 0

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
702554	GLENOSPHERE, 36MM	SHOULDER PROSTHESIS, REVERSE CONFIGURATION	PHX	EXACTECH, INC.	GLENOSPHERE, 36MM	UNK	10885862534934

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown