MAUDE Adverse Event Report: CAREFUSION AVAFLEX VERTEBRAL NEEDLE, 11G; CEMENT, BONE, VERTEBROPLASTY

Model Number AFH0011

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

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

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) - upon carefusion's investigations a follow up emdr submission will be submitted.

Event Description

Customer stated part of the broken avaflex needle broke in vertebrae.August 18, 2015 additional information received from end user: two separate patients were affected by same failure mode, product and lot number.Patients current state of health is stable and sustained no permanent injury as a result of failure mode and no further intervention needed.Broken part of needle was unable to be removed, however, procedure was completed as planned.T9 was the vertebrae affected.This complaint corresponds with (b)(4).

Manufacturer Narrative

Cfn-2015-5639; updated result code.Cfn-2015-5373: result code updated no complaint sample was provided for evaluation.Consequently, the investigation was not able to review the sample for the reported failure mode and no probable root cause could be identified.A device history record review was completed for lot 0000783563.No issues or deviations were identified that may have contributed to the reported failure mode.A probable root cause could not be determined from the reported failure mode since a complaint sample was not returned for evaluation and the dhr review did not identify any issues that may have contributed to the reported failure mode.Based on a trending review of previous complaints with a similar failure mode, it was noted a potential contributor to the reported failure mode was identified as an overstressing of the avaflex needle during the cement placement process resulting in the tip of the needle to crack and potentially break.However, since no complaint sample was available for evaluation, this potential contributor could not be evaluated for any contribution to a probable root cause.

Event Description

Patients have part of the broken avaflex needle in their vertebrae.(b)(6) 2015 additional information received from end user: two separate patients were affected by same failure mode, product and lot number.Patient¿s current state of health is stable and sustained no permanent injury as a result of failure mode and no further intervention needed.Broken part of needle was unable to be removed; however, procedure was completed as planned.T9 was the vertebrae affected.This complaint corresponds (b)(4) /mfg report # 1625685-2015-00194.

Manufacturer Narrative

H10: (b)(4); no complaint sample was provided for evaluation.Consequently, the investigation was not able to review the sample for the reported failure mode and no probable root cause could be identified.A device history record review was completed for lot 0000783563.No issues or deviations were identified that may have contributed to the reported failure mode.A probable root cause could not be determined from the reported failure mode since a complaint sample was not returned for evaluation and the dhr review did not identify any issues that may have contributed to the reported failure mode.Based on a trending review of previous complaints with a similar failure mode, it was noted a potential contributor to the reported failure mode was identified as an overstressing of the avaflex needle during the cement placement process resulting in the tip of the needle to crack and potentially break.However, since no complaint sample was available for evaluation, this potential contributor could not be evaluated for any contribution to a probable root cause.

• Brand Name: AVAFLEX VERTEBRAL NEEDLE, 11G
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5061799
• MDR Text Key: 25208185
• Report Number: 1625685-2015-00193
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AFH0011
• Device Lot Number: 0000783563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention; Required Intervention; Other
• Patient Sex: Female