FDA Adverse Event Malfunction Summary report: N

INSERT MT1S-10

MDR report key: 8878298 · Received August 9, 2019

Report

Report Number: 3003933619-2019-00005
Event Type: Malfunction
Date Received: August 9, 2019
Manufacturer: MECTRON S.P.A.
Product Code: JDX
PMA / PMN Number: K153743
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TWO INSERTS MT1S-10, LOT N.1900067, COMMERCIAL CODE 036000007, SINGLE USE ETO STERILIZED, EXPIRY DATE 2024 - 01 - 30, BROKEN DURING THE OPERATION ON (B)(6) 2019, THE FIRST ONE BROKE JUST AFTER 3 MINUTES USE. WHEN THE DOCTOR WAS USING THE INSERT WITH MEDICAL HANDPIECE (03120127 LOT. 408065149) BY PIEZOSURGERY PLUS (05170003 LOT. 416007560), DURING THE OPERATION FOR ENCEPHALOCELE REPAIR AND SKULL PLASTIC SURGERY ON (B)(6) 2019, THE 1ST ONE BROKE JUST AFTER 3 MINUTE USE. SO, HE CHANGED IT TO ANOTHER ONE AND TRIED TO USE IT, HOWEVER, THE 2ND ONE ALSO BROKE SOON. BOTH INSERTS WERE 1ST USE. THE MANUFACTURER MECTRON S.P.A. ASKED TO HIS DISTRIBUTOR IN (B)(6) , IMPLATEX CO., LTD., TO RETURN THE INSERTS MT1S-10 BROKEN TO DO AN INVESTIGATION. MANUFACTURER DOESN'T RECEIVED THE INSERTS MT1S -10, SUBJECT OF THIS MALFUNCTION, YET.

Description of Event or Problem · 1

THE DOCTOR PURCHASED MT1S-10 INSERTS ON (B)(6) 2019. WHEN HE WAS USING THE INSERT WITH MEDICAL HANDPIECE (03120127 LOT. 408065149) BY PIEZOSURGERY PLUS (05170003 LOT. 416007560) DURING THE OPERATION FOR ENCEPHALOCELE REPAIR AND SKULL PLASTIC SURGERY ON (B)(6) 2019, THE 1ST ONE BROKE JUST AFTER 3 MINUTE USE. SO, HE CHANGED IT TO ANOTHER ONE AND TRIED TO USE IT, HOWEVER, THE 2ND ONE ALSO BROKE SOON. THERE WAS NO ERROR MESSAGE. JUST BEFORE THE BREAKAGE, HE HEARD HIGH-PITCHED SOUNDS. BOTH INSERTS WERE 1ST USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
673600	INSERT MT1S-10	MT1S-10	JDX	MECTRON S.P.A.	MT1S-10	19000067

Patients

Seq	Age	Sex	Outcome	Treatment
1