MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE ELITE PASS NEEDLES; TRUEPASS NEEDLE STERILE

Model Number 72203793

Device Problem Material Fragmentation (1261)

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

Event Date 04/02/2014

Event Type  malfunction  

Event Description

During a rotator cuff repair utilizing the truepass needle, single pack, sterile it was reported that the tip broke off the device.It was not retrieved.The passer was the self-retrieving design.The broken piece wasn¿t found ¿ it may have been sucked up by the shaver; however, this cannot be confirmed.The patient¿s post-operative condition was fine.

Manufacturer Narrative

The two devices were investigated together.Both needles were dimensionally measured in thickness and width and confirmed to be within specification.The weld is intact and the needles demonstrate evidence of duraglide over the required length.One device has damage along the needle indicative of contact with a metal or hard surface.This device was exposed to loads not expected with passage of suture through soft tissue.The needle was passed without visualization (blind) and a secondary grasping instrument was also used blindly to grab the suture before retraction of the needle.This allowed the grasper to grip the needle directly and cause the damage noted above.Per ifu ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.As with any surgical device, careful attention should be exercised to ensure that excessive force is not placed on this device.Excessive force can result in the failure of this device.Ensure adequate visibility when using the device.(b)(4).

• Brand Name: ELITE PASS NEEDLES
• Type of Device: TRUEPASS NEEDLE STERILE
• Manufacturer (Section D): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3781713
• MDR Text Key: 4443024
• Report Number: 1219602-2014-00145
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/02/2014

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 Expiration Date: 01/31/2016
• Device Model Number: 72203793
• Device Catalogue Number: 72203793
• Device Lot Number: 50491215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2014
• Device Age: 3 MO
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1