MAUDE Adverse Event Report: CAREFUSION, INC DECKR RONG FCP 2X6MM CRV UP 5-1/2"(14CM); RONGEURS

Catalog Number NL6250

Device Problem Break (1069)

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

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6) on (b)(6) 2020 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.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

The following information was received via email: it was reported that doctor was using instrument to remove vertebral disk when the superior tip of the pituitary fell off.The doctor was using the instrument to remove vertebral disk when the superior tip of the pituitary fell off.(b)(6) 2020 additional information: did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes.It was retrieved with bayonet forceps.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.What was the patient¿s outcome? yes.It was retrieved with bayonet forceps.Good.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? yes.Do you have photos of the reported issue on the instrument? yes.No further information available.

Event Description

The following information was received via email: it was reported that doctor was using instrument to remove vertebral disk when the superior tip of the pituitary fell off.The doctor was using the instrument to remove vertebral disk when the superior tip of the pituitary fell off.08jun2020 additional information: 1.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes.It was retrieved with bayonet forceps.2.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.3.What was the patient¿s outcome? yes.It was retrieved with bayonet forceps.Good.4.Was the procedure completed as planned? yes.5.Can you please send all parts of the instrument for evaluation? yes.6.Do you have photos of the reported issue on the instrument? yes.No further information available.

Manufacturer Narrative

Follow up (b)(4).The sample was provided, and an evaluation was performed on the instrument.The root cause of the reported issue is due to improper use.Due to a notch in the spoon a slightly bent guiding part close to the breaking point of the moveable jaw, as well as the widened main mouth-part slot, it can be seen that hard material was cut and the jaw got turned sideways while cutting.When cutting hard material or turning the jaw sideways while cutting, the instrument is likely to break.The ifu excludes the use of the instrument at the central nervous system and the turning of the jaw sideways while sectioning.Each instrument must be inspected regarding damage or malfunction due to wear our prior use and must be maintained regularly.If the use of the instrument is as intended, a break from any parts is very unlikely.Additionally, the jaw is secured by two mounted pins which are also ensuring proper function.Only through unintended use by cutting hard tissue, bones, tearing tissue apart by turning the jaw sideway or failed hardening a breakage could occur.A hardness test is carried out for each batch and documented in the dhr.No errors were found in the hardening process.The affected instrument received a hardness of 43.5 rhc (measured retrospectively) which is within specification of 42-48hrc.The supplier hardens in-house and it is a validated process.The complete manufacturing records were checked.There were no deviations or non-conformances during the manufacturing process.No manufacturing, workmanship or material deficiency was identified.Stock was also checked and there was no deviation.It is the first reportable event of this batch.With the additional note that these forceps are only intended for cutting soft tissue.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.

• Brand Name: DECKR RONG FCP 2X6MM CRV UP 5-1/2"(14CM)
• Type of Device: RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10195263
• MDR Text Key: 202233779
• Report Number: 1423507-2020-00017
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL6250
• Device Lot Number: F19XWA
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other