MAUDE Adverse Event Report: CAREFUSION, INC RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN; RONGEUR, MANUAL

Catalog Number NL3785-16

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.

Event Description

Medwatch report received states: a small piece of metal ball tip from micro neuro nerve hook broke during surgery.Original intended procedure: cervical laminectomy.Date of event: (b)(6) 2017.Additional information received from the customer reporting, the product code was verified as micro nerve hook 3763.10, no lot number, the date of the event was (b)(6) 2017, no patient injury or intervention, the patient was stable after the event, the device broke but could not be found, the object was not retrieved, the patient required an additional x-ray.On (b)(6) 2017 x-ray cervical spine lateral, indication: fragmented surgical instrument with a missing fragment measuring approximately 5mm.Evaluate for foreign body.Comparison: on (b)(6) 2017: technique: intraoperative lateral radiographs of the cervical spine obtained on 2 images.Findings: there is no unexpected radiopaque foreign body at the operative site at the c5/c6 levels, or elsewhere within the visualized neck.Multiple staples overlie the neck.Patient is intubated.Impression: no radiopaque foreign body.The instrument was removed from use, and replaced with another in instrument set and the procedure was completed as planned.The customer verified the etchings on the device are: (b)(4).The device will not be returned and a picture was provided.

Manufacturer Narrative

Manufactured: aug, 2009.One (1) nl3785-16 vm rhoton ball dissector 3mm 90deg 7-1/2in was reported as the complaint.The lot code was reported as h09 (aug 2009), age of the sample was possibly around 8 years old.According to the complaint description, the small piece of the metal ball tip of the sample broke off during surgery.The broken off ball tip was not found in the patient upon searching and performing x-ray.Upon requests, the customer sent photos of the etching on the shaft part for identification purposes, but did not send photos of the sample¿s failure mode area nor the rest of the sample in for evaluations and investigations.One of the two photos provided was of the sample: the photo appeared to display only the original v.Mueller type etching on the shaft part; only the part number and lot code was visible and confirmed.Furthermore the sample photo appeared to display the satin finish, which is normally applied during v.Mueller manufacturing.Based on the customer description, the most likely affected part that broke off was the 3 mm wide rounded/ball type dissector tip that bends out at a 90 degree.The tip is manufactured to be 0.12 +/-0.01 inches in tip length and the neck width at the tip is manufactured to be at 0.020 in +/-0.003 in.This indicates that the dimensions of the tip are critical and the tolerances are tight.The nl3785-16 originates from a single piece of a 420 series stainless steel rod that is machined to shape, followed by final finishing steps necessary to refine and meet final print specifications.Upon bending of the tip and adjustments, the product is heat-treated to harden the metal to conforming hardness.It is unknown exactly where along the tip the sample broke off and what could be the possible root cause without conducting physical sample review.Device history records for nl3785-16 from lot code h09 were reviewed: all work instructions were completed accordingly.Qa inspections were performed.No issues related to the failure mode were identified.Conclusion(s): no sample was returned for evaluations and verifications.Dhr review did not indicate any issues with v.Mueller manufacturing and personnel.The sample photo was sent indicating only the etching on the shaft, the tip¿s failure mode or any other part of the sample was not visible to perform investigations hence a root cause could not be verified and concluded.It should be noted that bd/v.Mueller sales provide an alternative titanium made nl3785-16t product.Titanium is known to be stronger than steel.It is possible this product may be better suited for the customer.No device returned.

• Brand Name: RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 7271423
• MDR Text Key: 100282473
• Report Number: 1923569-2018-00003
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL3785-16
• Device Lot Number: H09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR