MAUDE Adverse Event Report: S&A MARTIN GMBH TA KERRISON RONG. 8'', 1MM BITE, 40? UP; RONGEUR, MANUAL

Model Number NL4291-81T

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 27jan2017 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Sales rep stated via email: during a procedure on (b)(6) 2016 it was noticed that the footplate of the kerrison (item# (b)(4)) had broken off.The patient was x-rayed to ensure the broken piece was not inside.The broken piece was reported to be found on the patient¿s top drape.The instrument and broken piece is currently in the possession of or nurse manager at centrastate medical center.No further information available.

Manufacturer Narrative

Follow up (b)(4).The sample was provided and an evaluation was performed.The instrument was manufactured in may of 2014.The root cause of the reported issue is due to unauthorized third party repair and inadequate functional inspection by healthcare facility prior to initiating procedure.The hardness was tested and found to be within specifications.Manufacturing records were reviewed and found to be conforming.The instrument and broken off tip were subject to microscopic examination.Several deep indentations in the material indicate that it was used to cut and/or manipulate thin, hard objects such as metallic wire.This does not correspond to its intended use (cutting of tissue and bone) and led to a reduction in material stability.Evidence of unauthorized third party repairs were also observed, for example, grinding of tip and cutting edges as well as of the shaft guide, which was shortened at the distal end, thus also reducing material stability and increasing the risk of fracture.There have been no issues identified with the material or manufacturing process.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: TA KERRISON RONG. 8'', 1MM BITE, 40? UP
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): S&A MARTIN GMBH; uhlandstrasse 17; rietheim-weilheim 78604 ; GM 78604
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6325480
• MDR Text Key: 67535130
• Report Number: 1423507-2017-00084
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL4291-81T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1