MAUDE Adverse Event Report: CAREFUSION RHOTON HOOK 90DEG BLUNT OVERLGTH 7-1/2IN; INSTRUMENT, MICROSURGICAL

Model Number NL3785-010

Device Problems Break (1069); Component Falling (1105)

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

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Maude report mw5055958 states "a micro dissector tip broke off inside the surgical site.Doctor was able to locate and remove the broken tip.The tip and the instrument were immediately removed from the sterile field.Additional information received 03nov2015: the customer reported there was no patient injury, broken tip removed.The tip broke off in the patient's body during a c4-c5 laminectomy.The physician was able to remove it.The physician was using the device at the time of the issue.The laminectomy was completed as planned.The device and tip will not be returned for investigation.

Manufacturer Narrative

(b)(4): one (1) nl3785-010 rhoton hook 90deg blunt overlgth 7-1/2in was reported as the complaint sample.Per complaint description the sample broke during the surgical procedure and the broken piece fell inside the patient.The broken piece was recovered and no patient injury or harm occurred.Sample was not sent in for evaluation or investigation.Sample was possibly removed or discarded by the end-user.Lot code a10 was reported.Device history records for nl3785-101 from lot code a10 could not be located for review.It is not known if there are any nl3785-101 products manufactured for lot a10.Customer may have reported wrong lot code.Product sample was not sent in for evaluations and investigations.Review of reference processes were normal and were not suspected to contribute to the reported failure mode description.Root cause could not be determined as the sample was not returned.The applicable personnel have been made aware of the complaint description and the reported failure mode.(b)(4).

• Brand Name: RHOTON HOOK 90DEG BLUNT OVERLGTH 7-1/2IN
• Type of Device: INSTRUMENT, MICROSURGICAL
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200 INC (ST. LOUIS); 5 sunnen dr; st. louis 63143
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5212144
• MDR Text Key: 31075697
• Report Number: 1923569-2015-00020
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NL3785-010
• Device Lot Number: A10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• 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