MAUDE Adverse Event Report: CAREFUSION MCCULLOCH HINGED RETRACTOR FRAME; RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Model Number NL9701-H

Device Problem Component Falling (1105)

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

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4): should additional information be received a follow-up emdr will submitted.

Event Description

The customer stated while the doctor was performing surgery this device fell apart, specifically at the hinge point of the item it fell apart.Patient involvement/harm reported as the parts fell into the cavity of the patient.The facility stated they were going to perform an x-ray on the patient as a precaution to see if all of the parts were retrieved.Additional information received 26 aug 2015: the customer reported, the event occurred at (b)(6) hospital, (b)(6) and is a division of (b)(6).There was no patient injury that i know of.An x-ray was obtained intra op.The parts to the retractor hinge were retrieved with a surgical instrument.The procedure was a complex tethered cord release.The procedure was completed as planned.I'm unsure of the patient's outcome.They were taken to the post anesthesia care unit as per routine after surgery.

Manufacturer Narrative

(b)(4).One nl9701-h mcculloch hinged retractor frame was returned as the complaint sample etching was noted to be legible, with the lot code yl ((b)(6) 1998), sample has possibly been in use for over 17 years.Per customer complaint description the sample fell apart at the hinge during surgery and the hinge pieces fell into the patient.Upon initial visual inspection the failure mode was confirmed on the moving arm with the ratchet mechanism; the hinge was disassembled, the 4 curved disc spring washers (10-300-331) and the ((b)(4)) flat head screw were returned.Signs of heavy usage, age related wear and tear on the surface finish, discoloration, and cleaning residues were noted all over the sample received.Upon closer visual inspection at 3 times magnification of the failed hinge area: no signs of loctite or adhesive on the threads of the screw and hinge were noted.Also no signs of removal or modification were observed on the surface of the flat head screw.It should be noted, the end of the screw was noted to peened/pressed in as normal manufacturing practice.It should be noted that current manufacturing assembly indicates the flat-head hinge screw that screws into the hinge joint is screwed in with loctite glue on the threads; this helps prevent the screw from unscrewing or backing out during normal handling and cleaning.During the time this complaint sample was manufactured in 1998, previous work instructions did not state to add loctite glue to the threads of the instruments.Loctite glue was added to work instructions in (b)(6) 2005.It is not known exactly how the screw of the hinge backed out and fell apart during the surgery procedure.It is most probable that the screw became loosened due to a combination of factors like: no loctite glue, old age and age related handling, wear and tear.No other defects or non conformances were noted on the sample.The ratcheting mechanism functioned normally, and no issues or signs of screw backing out or looseness were detected on the other stationary arm hinge joint.The screw on the stationary arm hinge joint was difficult to remove due to the peened/pressed in screw end.Based on the investigation of the affected returned sample: it is not known exactly how the failure mode occurred.It is mostly likely due to a combination of no loctite glue, old age and age related handling, wear and tear.Product was noted to be 17+ years old and previous work instructions did not indicate to secure hinge screws with loctite.It should be noted, current manufacturing assembly indicates the flat-head hinge screw that screws into the hinge joint is screwed in with loctite glue on the threads; this can prevent the screw from unscrewing or backing out during normal handling and cleaning.

• Brand Name: MCCULLOCH HINGED RETRACTOR FRAME
• Type of Device: RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
• 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: 5080954
• MDR Text Key: 26262687
• Report Number: 1423507-2015-00042
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NL9701-H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/1998
• 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