MAUDE Adverse Event Report: CAREFUSION, INC LEKSELL RONG JAW 3X16MM OVERLGTH 9-3/4IN; MANUAL RONGEUR

Catalog Number NL632

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 24oct2017 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.If additional information becomes available a follow up submission will be completed.Not returned.

Event Description

Medwatch report: a screw backed out of the rongeur during use.Instrument removed from table.Device usage problem: other.On 14nov2017 additional information: did any part the instrument fall into the patient¿s body, and if so how was it retrieved? the screw fell into the wound and was visible to the surgeon at the time of the occurrence, so he removed it and gave the instrument to the scrub tech to be removed from the surgical field.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no, not need because it was removed at the time of incident.

• Brand Name: LEKSELL RONG JAW 3X16MM OVERLGTH 9-3/4IN
• Type of Device: MANUAL RONGEUR
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061
• MDR Report Key: 7067443
• MDR Text Key: 93894913
• Report Number: 1423507-2017-00200
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: NL632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other