MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. INSTRUMENT 3747102 SUTURE PASSER; INSTRUMENT, ENT MANUAL SURGICAL

Model Number 3747102

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

It was reported that the weld on the product failed; the device separated at the handle.Analysis on the complaint device found that the tip had also broken off and was not returned.It has been confirmed that the tip of the device broke off ¿intra-operatively during a routine case.We were using the instrument to pass suture through a drill hole as directed.The tip was located and discarded in a sharps container.The patient was then washed thoroughly with antibiotic solution.There was no patient impact involved.¿.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: when received for analysis there was a residue consistent with biological contaminants; however, it could not be confirmed.When com pared to the assembly drawing: the silver solder joint was intact however the rod/shaft had become detached from the handle which would have resulted in the reported malfunction.The rod/shaft was bent in 2 places and the tip was broke off which would have measured approximately 0.06¿ [the location of this piece is unknown].When viewed under magnification, there were scratches/gouges along the rod/shaft.The information indicates that the device was mishandled which likely caused the separation of the rod from the handle.Method: microscopic inspection.Results: stress problem, fracture problem.

• Brand Name: INSTRUMENT 3747102 SUTURE PASSER
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive 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: 3789837
• MDR Text Key: 4439699
• Report Number: 1045254-2014-00099
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2014

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: 3747102
• Device Catalogue Number: 3747102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2014
• Initial Date FDA Received: 05/05/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 00060 YR
• Patient Weight: 59