MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL UNKNOWN DUMMY MATERIAL

Catalog Number SURGICAL UNKNOWN

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample has not been returned for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event from medwatch: during a posterior spinal fusion the physician was removing the disc using an upbiting pituitary ronguer.The tip broke off inside the patient.It took the physician an additional 20 minutes of surgery time to find and remove the tip from the patient.The pituitary ronguers were taken out of service.The patient's condition was reported as unknown.

Manufacturer Narrative

Qn#(b)(4).Device history record (dhr) was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to rongeurs.A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.No concerns were noted in the device history record.

Event Description

Alleged event from medwatch: during a posterior spinal fusion the physician was removing the disc using an upbiting pituitary ronguer.The tip broke off inside the patient.It took the physician an additional 20 minutes of surgery time to find and remove the tip from the patient.The pituitary ronguers were taken out of service.The patient's condition was reported as unknown.

• Brand Name: SURGICAL UNKNOWN DUMMY MATERIAL
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5460900
• MDR Text Key: 39449756
• Report Number: 3011137372-2016-00024
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention