FDA Adverse Event Malfunction Summary report: N

EQUINOXE

MDR report key: 12343766 · Received August 19, 2021

Report

Report Number: 1038671-2021-00403
Event Type: Malfunction
Date Received: August 19, 2021
Date of Event: June 30, 2021
Report Date: September 22, 2021
Manufacturer: EXACTECH, INC.
Product Code: KWT
UDI-DI: 10885862515742
PMA / PMN Number: K162726
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

SECTION H10: H3: THE ORIGIN OF THE FRAGMENT REPORTED CANNOT BE DETERMINED BECAUSE ALL OF THE IMPLANTS UTILIZED ARE MADE FROM THE SAME TITANIUM ALLOY, TI-6AL-4V. THE SURGEON RESPONDED APPROPRIATELY AFTER NOTICING THE FRAGMENT AND REMOVED IT FROM THE WOUND SITE. NO ADDITIONAL FRAGMENTS ARE VISIBLE IN THE PROVIDED X-RAY IMAGES.

Additional Manufacturer Narrative · 1

PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-10-00, 6867294 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-20-00, 6811300 - EQ REVERSE TORQUE DEFINING SCREW KIT.

Description of Event or Problem · 1

AS REPORTED, DURING A LEFT SHOULDER PROCEDURE ON A MALE PATIENT, AFTER THE STEM AND THE TRAY WERE ASSEMBLED, THE SURGEON IMPLANTED THE ASSEMBLY INTO HUMERUS. AT THAT TIME, HE FOUND ONE (1) SMALL FRAGMENT ON SURFACE OF GREATER TUBERCLE. HE PICKED IT UP FROM SURGICAL FIELD APPROPRIATELY. IT WAS UNKNOWN WHERE THE FRAGMENT CAME FROM. THE FACILITY HAS A THIRD PARTY (LAB) ANALYZE THE FRAGMENT USING ICP MASS SPECTROMETER, AND AS A RESULT, THIS FRAGMENT MATERIAL WAS DETECTED WITH HIGH POSSIBILITY AS TI ALLOY. THE DEVICES WERE IMPLANTED; HOWEVER, THE FRAGMENT IS TO BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1241919	EQUINOXE	PRESERVE STEM 6MM	KWT	EXACTECH, INC.	300-30-06	UNK	10885862515742

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R