MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XOMED® INSTRUMENTS; INSTRUMENT, ENT MANUAL SURGICAL

Model Number 3747102

Device Problem Material Fragmentation (1261)

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

Event Date 07/28/2014

Event Type  malfunction  

Event Description

It was reported that the ¿tip broke off the suture passer.¿ there was no reported patient impact.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: analysis on 3747102, suture passer, lot 0208040928, found that when compared to the assembly drawing: the tip was broken off which would have resulted in the reported malfunction.When viewed under magnification, it broke at the low point of the hook.The piece that broke off would have measured approximately 0.06¿ x 0.04¿ [this piece was not returned].(b)(4).

• Brand Name: XOMED® INSTRUMENTS
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4029763
• MDR Text Key: 18290329
• Report Number: 1045254-2014-00197
• Device Sequence Number: 1
• Product Code: LRC
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3747102
• Device Catalogue Number: 3747102
• Device Lot Number: 0208040928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2014
• 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 Age: 00048 YR
• Patient Weight: 60