MAUDE Adverse Event Report: COVIDIEN NON-VENTED STRAIGHT TIP; YANKAUER

Model Number FG71-24227

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 04/17/2015.Please see investigation summary below: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.Based on previous evaluations on samples reported with a similar failure mode, a walk through of the machine was done to see if any anomalies were observed.All procedures are being followed accordingly.The potefntial root cause identified was that during the molding process of the product the material could have degradation creating weakness on the product tip.Degradation of the material can be originated due to wear of the barrel and screw of the molding machine.As a corrective action, the cleaning of the barrel and screw were performed, the check sensor was changed and accessories were cleaned for contamination.The current process is running according to product specifications meeting quality acceptance criteria.The appropriate personnel involved in the process were made aware of this complaint to raise awareness of this type of condition reported.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will also be used for tracking and trending purposes.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a yankauer.The customer reports the yankauer tip broke off into the patient.The tip was not found on x-ray, so the doctor believes it was cemented into the bone.There was injury reported.The customer further reports that the yankauer tip was being used to access the canal of the femur, during the reaming process.The surgical team took x-rays to observe the tip, according to aorn standards, but they were unable to locate it upon examination of films.The doctor pulsavac¿d the wound/femoral canal, but they were unable to retrieve tip from the canal.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: NON-VENTED STRAIGHT TIP
• Type of Device: YANKAUER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 9217 3; MX 92173
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4601365
• MDR Text Key: 20516853
• Report Number: 9612030-2015-00022
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

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 Model Number: FG71-24227
• Device Catalogue Number: FG71-24227
• Device Lot Number: 416431064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 03/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1