MAUDE Adverse Event Report: CAREFUSION DECKER RONGEUR CUP 2 X 6MM STR 6IN

Model Number NL6250

Device Problem Fracture (1260)

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

Event Date 02/27/2015

Event Type  malfunction  

Event Description

Broken customer stated "broke during a procedure, the jaw tip that fracture was recovered during the case." sample is available with sales rep.Will issue a ups call tag.Credit/replacement wasn't specified.Additional information 3/17/2015: the procedure being performed was a micro lumbar distectomy, the patient required no medical intervention.Another instrument was used to complete the case.

Manufacturer Narrative

(b)(4)- if additional information becomes available, a follow up emdr will be submitted.

Manufacturer Narrative

(b)(4).It was reported by the customer that the instrument "broke during a procedure, the jaw tip that fracture was recovered during the case.The type of procedure being performed at the time was a micro lumbar discectomy.The patient did not require any medical intervention¿.The instrument was returned and an evaluation was performed.The instrument was manufactured in december of 2012.Upon evaluation, it was observed that the movable upper jaw is broken.There were no abnormalities or scratches on the surface of the instrument.The hardness of the instrument was measured and found to be at 43 hrc, which is within specification.The dimensions are also within tolerance.It appeared that the instrument was used for cutting hard material such as a bone.The root cause was determined to be misuse by the user.There were no issues identified with the material or manufacturing process that would have contributed to the reported issue.A review of the complaint system was performed for this instrument over the last two years.There have been no other reported complaints for this same issue with this instrument.The reported issue will continue to be trended and evaluated.

• Brand Name: DECKER RONGEUR CUP 2 X 6MM STR 6IN
• Type of Device: RONGEUR
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4635557
• MDR Text Key: 5753682
• Report Number: 1423507-2015-00029
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NL6250
• Device Catalogue Number: NL6250
• Device Lot Number: XWAR12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other