FDA Adverse Event Malfunction Summary report: N

PECA

MDR report key: 19135402 · Received April 18, 2024

Report

Report Number: 3010673777-2024-00001
Event Type: Malfunction
Date Received: April 18, 2024
Date of Event: February 22, 2024
Report Date: April 18, 2024
Manufacturer: NOVASTEP S.A.S - RENNES - FRANCE
Product Code: HXX
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

FOR REMOVAL PROCEDURE, NOVASTEP SAS REQUIRES THE USE OF SPECIFIC DEVICES : REMOVAL SCREWDRIVERS. THEY MAY BE SUPPLIED ON DEMAND. THEY DIFFERS FROM INSERTING SCRWDRIVERS ESPECIALLY AS THEY HAVE NO CANNULA, ENSURING AN IMPROVED MECHANICAL RESISTANCE THAT REDUCE RISKS OF BREAKAGE, AND A "WIRE" TIP FOR REMOVING THE TISSUE AND EASE THE ACCESS TO THE SCREW.ACCORDING TO AVAILABLE DATA, THE PHYSICIAN DID NOT USE THIS DEVICE.

Description of Event or Problem · 0

INFORMATION RECEIVED ON 2024-03-20. EXACT-T10 PECA SCREWDRIVER TIPS BROKE DURING A HARDWARE REMOVAL CASE. DETAILS: A 3.0 PECA SCREW WAS CAUSING THE PATIENT PAIN. THE DOCTOR INTENDED TO REMOVE THE 3.0 AND AN ADDITIONAL 4.0 PECA SCREW. REMOVAL OF THE 3.0 SCREW ACHIEVED, THOUGHT TO BE THE CAUSE OF IRRITATION ACCORDING TO THE DOCTOR. FAILURE TO REMOVE 4.0 PECA SCREW: THE TOP OF THE XSD04004 BROKE, TWICE. CONTEXT: THE 4.0 SCREW HAD A LOT OF BONE GROWTH AROUND IT. SCREWDRIVER LINED UP PERFECTLY WITH THE SCREW. CONSEQUENCES: THE 4.0 SCREW WAS LEFT IN. SURGICAL DELAY OF 15-20 MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
540823	PECA	EXACT T10 SCREWDRIVER	HXX	NOVASTEP S.A.S - RENNES - FRANCE	XSD04004	I03113

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other