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

Catalog Number 72203793

Device Problems Break (1069); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It is reported that the tip of the needle got broken off when the surgeon grasped the tissue with the jaws of the truepass suture passer and manipulated the trigger in order to pass the suture.The report states that the needle tip was unable to be retrieved and was left in the patient.The procedure was completed with a back-up device.There is no report on post-operative patient condition.

Manufacturer Narrative

Device returned to manufacturer on 4 january, 2016.Evaluation narrative - one truepass needle was returned for evaluation.Visual examination of the needle confirmed the reported complaint.The needle tip has broken off at the suture slot.Broken tip was not returned.(b)(4).

• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5339150
• MDR Text Key: 34868934
• Report Number: 1219602-2015-01273
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 72203793
• Device Lot Number: 50510074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2014
• 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
• Patient Outcome(s): Required Intervention