MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS NEEDLE SINGLE PACK STERILE BX 5; ACCESSORIES,ARTHROSCOPIC

Model Number 72203793

Device Problems Break (1069); Detachment Of Device Component (1104); Misfire (2532)

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

Event Date 02/06/2018

Event Type  malfunction  

Event Description

It was reported that the truepass was not firing properly out of the truepass instrument, and it was not catching the suture, plus the tip broke off.No patient injury was reported.

Manufacturer Narrative

One 72203793 truepass single needle returned.These are sold as a pack of five sterile individual needles.The complaint stated: ¿as reported: faulty, wasn't firing properly out of the truepass instrument, and wasn't catching the suture, plus the tip broke off.¿ the broken needle was confirmed.The nitinol tip has been snapped at the suture slot area.The piece would be approximately 0.146¿.It was not returned.It was asked twice, but was not confirmed whether the fragment was retrieved from the patient.The associated suture passer was not returned.There is no way to confirm instrument involvement or failure.Due to the needle damage, it cannot be tested in an alternate instrument either.The fractured suture slot condition indicates material stress was involved.Dimensions taken were nominal.Root cause related to the manufacture of the device was not confirmed.

• Brand Name: TRUEPASS NEEDLE SINGLE PACK STERILE BX 5
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7273702
• MDR Text Key: 100251740
• Report Number: 1219602-2018-00226
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885554030433
• UDI-Public: (01)00885554030433(17)190820(10)50516921
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2019
• Device Model Number: 72203793
• Device Catalogue Number: 72203793
• Device Lot Number: 50516921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• 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