MAUDE Adverse Event Report: CAREFUSION, INC DECKER RONGEUR CUP 2 X 6MM STR 6IN; RONGEURS

Catalog Number NL6250

Device Problem Break (1069)

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

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).On (b)(6) 2019 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

Via email: the pituitary broke while in use.The doctor was removing vertebral disc when it happened.(b)(6) 2019 additional information: what was the procedure that was being performed? laminectomy.Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? yes.Retrieved by forceps.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no x-ray was taken.What was the patient¿s outcome? normal.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? missing one portion of the pituitary.No further information available.

Manufacturer Narrative

The sample was provided, and an evaluation was performed.The root cause of the reported issue is due to improper use.The investigation found the main jaw part has two dents and a notch on the right side, the main mouth part slot/slide slot is very wide, a bent rag on the mouth part, and the instrument, due to the lack of lateral guidance, no longer cuts properly.The supposed reason of damage is due to defects in maintenance, and overloading of the device.A laminectomy is a surgical procedure that removes a portion of the vertebral bone called the lamina.The back muscles are pushed aside rather than cut and the parts of the vertebral adjacent to the lamina are left intact.Per our instruction for use our decker rongeur cup is only intended for gripping and cutting soft tissue.Due to the dents and the notch on the main mouth part, as well as the widened main mouth part slot, it can be seen that hard material was cut with the instrument.When cutting hard material, the instrument is likely to break.The ifu excludes the use of the instrument at the central nervous system and not used to tear the tissue apart by turning the jaw sideways.Each instrument must be inspected regarding damage or malfunction due to wear prior to use and must be maintained regularly.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 supplier hardens in-house and it is a validated process.The instrument was within the hardness range of 42hrc -48hrc.Therefore, failed hardness can be excluded.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.Device was not used as intended.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.

Event Description

Via email: the pituitary broke while in use.The doctors was removing vertebral disc when it happened.21nov2019 additional information: 1.What was the procedure that was being performed? lamintectomy 2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes.Retrieve by forceps 3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no xray was taken 4.What was the patient¿s outcome? normal 5.Was the procedure completed as planned? yes 6.Can you please send all parts of the instrument for evaluation? missing one portion of the pituitary.

• Brand Name: DECKER RONGEUR CUP 2 X 6MM STR 6IN
• Type of Device: RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 9403775
• MDR Text Key: 202229070
• Report Number: 1423507-2019-00019
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: XWAT10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other