FDA Adverse Event Malfunction Summary report: N

STAR INSTRUMENTS KIT STERILE PACKAGED

MDR report key: 7907613 · Received September 25, 2018

Report

Report Number: 0008031020-2018-00634
Event Type: Malfunction
Date Received: September 25, 2018
Date of Event: August 28, 2018
Report Date: December 20, 2018
Manufacturer: STRYKER GMBH
Product Code: NTG
UDI-DI: 00886385015767
PMA / PMN Number: P050050
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE REPORTED EVENT THAT STAR INSTRUMENTS KIT STERILE PACKAGED WAS ALLEGED OF 'LASER MARKING/PRINTING FADING/FLAKING' COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE COULD HAVE BEEN CAUSED BY THE CONTACT OF THE STERI-DOT WITH "ACETONE", WHICH IS USED AS A CLEANING AGENT DURING MANUFACTURING. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RETURNED STERILE INNER POUCHES WERE RETURNED AND DO INDEED SHOW SOME RED DEBRIS ALL OVER THEM. IT CAN BE CONFIRMED THAT THE RED DEBRIS ARE COMING FROM THE STERILIZATION DOTS SINCE THE WELL-KNOWN RED PATTERN OF THE GAMMA SIGN CAN BE IDENTIFIED.

Description of Event or Problem · 0

DEBRIS FOUND ON SINGLE USE INSTRUMENT PACK 100-0071 (OUTSIDE AND ON INSTRUMENT), WHICH IS LIKELY TO PEEL OFF FROM THE RED LABEL.

Additional Manufacturer Narrative · 1

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

DEBRIS FOUND ON SINGLE USE INSTRUMENT PACK (B)(4) (OUTSIDE AND ON INSTRUMENT), WHICH IS LIKELY TO PEEL OFF FROM THE RED LABEL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
746681	STAR INSTRUMENTS KIT STERILE PACKAGED	PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME	NTG	STRYKER GMBH		L14851	00886385015767

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other