MAUDE Adverse Event Report: MEDTRONIC XOMED INC. ROTATING BACKBITER, PED. 1/EA; FORCEPS, ENT

Model Number 3712013

Device Problem Material Fragmentation (1261)

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

Event Date 05/07/2014

Event Type  malfunction  

Event Description

The customer reported that near the tip of the instrument, a piece is snapped off.The instrument was found on an instrument tray during surgery on (b)(6) 2014.There was no injury or impact to the patient reported.The customer was not aware of any fragment of the instrument having to be removed from the patient.

Manufacturer Narrative

(b)(4).The device has not been returned.An evaluation/analysis of the devices cannot be performed at this time.

Manufacturer Narrative

The instrument was received in an unlabeled padded foam medtronic instrument box.The shaft of the instrument was found bent which was indicative of aggressive use of the instrument by the customer.The instrument was found fractured near the tip which caused the backbiter to not function upon actuation of handle.Upon observing the fractured location, there was some amount of corrosion observed which may have likely deteriorated the material and when compounded with excessive force by the customer during use, the instrument fractured at this location.There was no evidence of improper manufacturing, therefore manufacturing has been ruled out as a potential cause.Based on the above observations; the most likely underlying cause is consistent with mishandling, based on the bent shaft which indicated aggressive use of the instrument and the fractured point.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ROTATING BACKBITER, PED. 1/EA
• Type of Device: FORCEPS, ENT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 3836060
• MDR Text Key: 18302109
• Report Number: 1045254-2014-00123
• Device Sequence Number: 1
• Product Code: KAE
• 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: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3712013
• Device Catalogue Number: 3712013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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