FDA Adverse Event Malfunction Summary report: N

LO-PRO SCRW,TI,3.5MMX 22MM

MDR report key: 16608957 · Received March 24, 2023

Report

Report Number: 1220246-2023-06479
Event Type: Malfunction
Date Received: March 24, 2023
Date of Event: February 22, 2023
Report Date: September 5, 2024
Manufacturer: ARTHREX, INC.
Product Code: HWC
UDI-DI: 00888867050488
PMA / PMN Number: K203294
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION AND/OR EXCESSIVE FORCE BEING USED DURING INSERTION OF THE SCREW.

Additional Manufacturer Narrative · 0

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 0

ON 3/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935-22 LOW PROFILE SCREW HEAD BROKE DURING INSERTION. THE BODY OF THE SCREW WAS IDEALLY IMPLANTED AND WAS USED TO COMPLETE THE CASE. THE HEAD OF THE SCREW WAS REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A FIBULAR FRACTURE PROCEDURE ON (B)(6) 2023.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
377069	LO-PRO SCRW,TI,3.5MMX 22MM	SCREW, FIXATION, BONE	HWC	ARTHREX, INC.	LO-PRO SCRW,TI,3.5MMX 22MM		00888867050488

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown