FDA Adverse Event Malfunction Summary report: N

SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30

MDR report key: 8964023 · Received September 5, 2019

Report

Report Number: 3005180920-2019-00741
Event Type: Malfunction
Date Received: September 5, 2019
Date of Event: August 7, 2019
Report Date: September 5, 2019
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LPH
UDI-DI: 07630030812392
PMA / PMN Number: K103721
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 14 AUGUST 2019: LOT 1902135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-APR-2019. EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE OTHER SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: PRELIMINARY INVESTIGATION PERFORMED ON 03 SEPTEMBER 2019. THE HEAD OF THE SCREW SHEARED OFF FROM THE BODY AND THE IMAGE SHOW THE HEAD STILL CONNECTED WITH THE RELATED SCREWDRIVER. THE ROOT CAUSE OF THIS EVENT CAN BE RELATED TO AN EXCESSIVE FLEXION APPLIED TO THE SCREW DURING INSERTION, BUT FROM THE RECEIVED INFORMATION IT IS NOT SUFFICIENT TO DETERMINE IT WITH CERTAINTY.

Description of Event or Problem · 1

DURING THE PRIMARY HIP SURGERY, AND WHILE THE SURGEON WAS MANUALLY INSERTING THE SCREW INTO THE ACETABULUM, THE SCREW HEAD SHEARED OFF. THE SHAFT OF THE SCREW WAS LEFT INSIDE OF THE PATIENT'S ACETABULUM AND THE SCREW HEAD WAS RECOVERED. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
761650	SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30	CANCELLOUS BONE SCREW	LPH	MEDACTA INTERNATIONAL SA		1902135	07630030812392

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other