MAUDE Adverse Event Report: WENZLER GMBH CHROMA-LINE BLUE KERR RONG 8IN 2MM BITE; RONGEUR, MANUAL

Model Number NL4273-82

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).On 4/27/2016 customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information may be available.Confirmation was also requested from the customer that there was no patient impact associated with reported issue.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Customer stated via email: it has a burr on the side and back of the tip, in which it resulted in a tear in the dura.The dura tear was repaired.The patient received a normal recovery and was discharged with special instructions for a dura tear.On 27apr2016 additional information: was the product received in this condition: no.If not, what was the product being used for when it was observed that has a burr on the side and back of the tip: revision right l4/5 lfd.What procedure did the patient have to undergo for the torn dura: the doctor had to do a dura repair, he stitched it with 6-0 prolene suture.Please provide any other details regarding patient impact.Patient had to lay flat for 60 minutes.The patient was discharged with special instructions to follow for a dura tear.

Manufacturer Narrative

(b)(4).The sample was provided and an evaluation was performed.The instrument was manufactured in june of 2014.The incident is not caused by a burr on the instrument.There is no visible burr present, confirmed through magnification at the tip of the instrument.The instrument failed the cutting test.The jaw of the instrument is bent and in a much worn condition.The tip is damaged by misuse and modification, and the footplate is modified and thereby weakened.The instrument was disassembled by an unauthorized 3rd party repair company.The supplier manufactured and delivered the instrument with a handle screw, which was secured by laser welding dots, so it is not possible that this instrument came apart during surgery.To remove this screw, excessive force with a screwdriver is required.On this instrument, all laser welding dots are broken.It is like a broken seal.Also the screw slot is damaged.The tear in the dura was most likely caused by misuse, worn condition, modification of the instrument by an unauthorized 3rd party repair company, no cutting action, and bending of the instrument through mechanical overload.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: CHROMA-LINE BLUE KERR RONG 8IN 2MM BITE
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): WENZLER GMBH; steigäcker 22; balgheim 78582 ; GM 78582
• 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 ; 8473628063
• MDR Report Key: 5656700
• MDR Text Key: 45234481
• Report Number: 1423507-2016-00059
• 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: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL4273-82
• Device Lot Number: XWDV06
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other