MAUDE Adverse Event Report: S&A MARTIN GMBH T-COAT MICRO HDL KERR RONG 8IN 2MM BITE; RONGEUR, MANUAL

Model Number NL4251-82T

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 20mar2017, 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.

Event Description

Medwatch report (b)(4) received states: during surgery the tip of a gold #2 kerrison rongeur broke off during the procedure.Broken tip was retrieved intact by surgeon.Intended procedure: laminectomy with posterolateral fusion.No further information available.

Manufacturer Narrative

(b)(4).The sample was provided and an evaluation was performed.The reported issue that the tip broke off was confirmed through visual examination.The instrument was manufactured in november of 2010.The root cause of the reported issue is due to normal wear and tear for an end of life instrument.The cutting edges are worn (blunt), which means an increased effort was required to use the instrument.The hardness was within tolerance at 45.3 hrc (range 43-48 hrc).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: T-COAT MICRO HDL KERR RONG 8IN 2MM BITE
• 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: 6428048
• MDR Text Key: 70971711
• Report Number: 1423507-2017-00086
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL4251-82T
• Device Lot Number: XMEM11
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• Type of Device Usage: N
• Patient Sequence Number: 1