FDA Adverse Event Malfunction Summary report: N

CHROMA-LINE BLUE KERRISON RONGEUR 8IN 2MM BITE

MDR report key: 5700143 · Received June 6, 2016

Report

Report Number: 9611616-2016-00001
Event Type: Malfunction
Date Received: June 6, 2016
Date of Event: April 26, 2016
Report Date: June 6, 2016
Manufacturer: RAIMUND WENZLER GMBH
Product Code: HAE
PMA / PMN Number: PREAMENDMENT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

MICROSCOPIC EVALUATION REVEALED THAT NO BURR IS PRESENT ON THE DEVICE. THE INSTRUMENT HAD BEEN DISASSEMBLED BY UNAUTHORIZED SERVICE COMPANY (SAFETY WELDING BROKEN BY APPLICATION OF FORCE ON SCREW, SCREW SLOT DAMAGED). CUTTING TEST FAILED. THE DEVICE SHOWED EXCESSIVE WEAR, THE TIP AND FOOTPLATE BEING DAMAGED BY UNAUTHORIZED REPAIR AND/OR MODIFICATION, JAW BENT. REVIEW OF MANUFACTURING RECORDS SHOWED NO ISSUES. CUSTOMER INSTRUCTED TO PERFORM FUNCTION CHECK OF DEVICE BEFORE REUSE AND NOT TO USE MODIFIED INSTRUMENTS.

Description of Event or Problem · 1

PER CUSTOMER STATEMENT, A BURR ON THE SIDE AND BACK OF THE TIP RESULTED IN A TEAR IN THE DURA. THE DURA TEAR WAS REPAIRED. THE PATIENT RECOVERED NORMALLY AND WAS DISCHARGED WITH SPECIAL INSTRUCTIONS FOR A DURA TEAR. ADDITIONAL INFORMATION (04/27/2016): THE PRODUCT WAS NOT RECEIVED IN THIS CONDITION. IT WAS BEING USED FOR A REVISION RIGHT L4/5 LFD WHEN IT WAS OBSERVED THAT IT HAD A BURR ON THE SIDE AND BACK OF THE TIP. THE DOCTOR HAD TO DO A DURA REPAIR, STITCHING IT WITH 6-0 PROLENE SUTURE. THE PATIENT HAD TO LAY FLAT FOR 60 MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357060	CHROMA-LINE BLUE KERRISON RONGEUR 8IN 2MM BITE	RONGEUR	HAE	RAIMUND WENZLER GMBH		27141981

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention