MAUDE Adverse Event Report: CAREFUSION DISCONTINUED- SUB NL4273-83; RONGEUR, MANUAL

Model Number L-1173

Device Problem Component Missing (2306)

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

Event Date 06/30/2014

Event Type  malfunction  

Event Description

The following information was initially sent to the customer's distributor ((b)(4)) from the end user facility ((b)(4)) via email on (b)(4) 2014: "on (b)(6) mid case it was noticed that  a screw was missing from the #3 rongeur.  it had been functioning correctly up to that point on the case.  we could not find the screw.  it was not in the wound nor in the trays.  we checked fairly well.  plus x rayed the patient just to be safe.  we have submitted the 3500a form to the fda and completed a variance report".  (b)(6) at (b)(6) responded to (b)(6) on (b)(6) 2014 indicating "we do not represent v.Mueller".  on (b)(6) 2014 (b)(6) of (b)(6) at (b)(6) contacted the carefusion sales rep ((b)(6)) to report the incident.  a medwatch from was also submitted by (b)(6): "dr.(b)(6) was using device kerrison #3.  no problems noted when initially used.  then kerrison fell apart and noticed that screw was missing.  kerrison was then taken out of circulation".  the customer responded indicating that there was no patient harm.The customer did take one additional x ray to confirm they had not missed the broken piece.Additional information received from the customer on (b)(6) 2014.The event took place on (b)(6) 2014.The procedure was a (b)(4).There was no injury to a patient or healthcare professional as a result of the reported issue.There was no medical or surgical intervention required as a result of the reported issue.The procedure was delayed in order to examine wound for the screw and to perform an x-ray.Another kerrison was required to complete the surgery.The case was completed? the biting sequence of the product inspected prior to surgery.The device failed after few bites of bone.It is unknown if the instrument has ever been repaired.The instrument has been previously refurbished/repaired by a third party.A maude event report was filed with the fda by the facility.The purchase order # is not known.It is unknown when the instrument was purchased.

Manufacturer Narrative

(b)(4).The complaint device has been sent to the supplier for evaluation.To date, an evaluation has not been completed.A follow up will be sent if an evaluation of the complaint device is performed.

Manufacturer Narrative

(b)(4).The complaint instrument was returned and an evaluation was performed by the manufacturer.The instrument was manufactured in january of 2007, and may have been in use by the customer for over seven years.It was observed that the screw was missing and the rongeur had fallen apart.It was immediately observed that the instrument has been modified by a third party.The distal tip was improperly reworked, which has removed some of the material from the tip.The instrument¿s coating had also been partially removed at the tip.When manufactured, the screw fits flush with the instrument and is laser welded in three places.All three of the laser welds have been broken on this screw/instrument.The laser welds are checked as part of the final inspection prior to release of the instrument.If repaired, the screw would need to be laser welded again.It appears that the original screw was not used after the repair was made.However, the screw was never returned by the customer.It was also observed that two of the springs were not the original black coated ball springs that are original components of this rongeur.One of the springs is non-coated and one is marked with ¿sample¿.The end of the spring was bent and caused a deep scratch into the handle.The second spring is also non-coated and marked with the number ¿8802-b¿.Both numbers were etched by a third party.In addition, both of these springs were the incorrect dimensions.There was no workmanship failure identified during the manufacture of the instrument.A review of the device history record (dhr) was performed for this lot.There were no issues identified with the material or manufacturing process that would have contributed to the reported issue.A review of the carefusion complaint system was performed for this instrument over the last four years.There have been no other reported complaints of any kind for this instrument during this time period.The reported issue will continue to be trended and evaluated by carefusion.

• Brand Name: DISCONTINUED- SUB NL4273-83
• Type of Device: RONGEUR, MANUAL
• 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: 3968287
• MDR Text Key: 18730518
• Report Number: 1423507-2014-00018
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: L-1173
• Device Lot Number: XWDG01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2014
• 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 Age: 49 YR
• Patient Weight: 86