FDA Adverse Event Injury Summary report: N

T15 HEXALOBE, ISO, CANN.

MDR report key: 17287982 · Received July 10, 2023

Report

Report Number: 1220246-2023-07101
Event Type: Injury
Date Received: July 10, 2023
Date of Event: June 14, 2023
Report Date: December 3, 2024
Manufacturer: ARTHREX, INC.
Product Code: LXH
UDI-DI: 00888867263765
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT HAS NOT YET BEEN DETERMINED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A MOST LIKELY CAUSE IF A ROOT CAUSE CAN NOT BE DETERMINED.

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-8750-03, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OBSERVED THAT THE DRIVER TIP WAS BROKEN OFF. THE MOST PROBABLE CAUSE IS APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION/USE OVER-TORQUING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.

Description of Event or Problem · 0

ON 6/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8750-03 DRIVER SHAFT, T15 HEXALOBE BROKE WHEN ADVANCING THE SCREW. SOME OF THE BROKEN FRAGMENTS WERE RETRIEVED, BUT THE REST REMAINS STUCK IN THE BONE. THIS WAS DISCOVERED DURING AN INTRAMEDULLARY METATARSAL FRACTURE ORIF PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITH A SECOND DRIVER. ADDITIONAL INFORMATION REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
805708	T15 HEXALOBE, ISO, CANN.	ORTHOPEDIC MANUAL SURG INSTR	LXH	ARTHREX, INC.	T15 HEXALOBE, ISO, CANN.	011935	00888867263765

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other