MAUDE Adverse Event Report: SYNTHES GMBH ROD CUTTER; CUTTER,WIRE

Catalog Number 03.614.021

Device Problems Break (1069); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2012

Event Type  malfunction  

Event Description

It was reported that, during a posterior cervical procedure, when the surgeon and surgical tech went to cut, the top of the head blade cutter broke off because of the pressure.There were no pieces to retrieve, and no adverse event to the patient.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A review of the device history shows revealed no irregularities.The hardness was measured at the time of manufacture and found to be good.The material was researched and is also conforming.Subject device was received with one of the cutter blades broken off at the hinge pin.The hardness was re-inspected and was found to be conforming quite similar to the hardness test at time of manufacture.This complaint has been deemed invalid.Placeholder.

• Brand Name: ROD CUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4348341
• MDR Text Key: 5177427
• Report Number: 8030965-2014-01655
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.614.021
• Device Lot Number: T946888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2012
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR