MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS SUTURE PASSER SELF-CAPTURE; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72203791

Device Problem Mechanical Problem (1384)

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

Event Date 11/07/2016

Event Type  malfunction  

Event Description

It was reported that there is a small spring that forces the capture mechanism to close and holds the suture in place, this spring came out of its place.No patient injury or complications were reported.

Manufacturer Narrative

One truepass suture passer w/self-capture feature was returned for evaluation.Visual assessment of the returned device confirmed the torsional spring to be dislodged from the recessed grooves but remains attached to the top jaw.A root cause investigation has been opened to address this failure mode.

• Brand Name: TRUEPASS SUTURE PASSER SELF-CAPTURE
• 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 w. william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6166291
• MDR Text Key: 62420095
• Report Number: 1219602-2016-01360
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2016

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 Catalogue Number: 72203791
• Device Lot Number: 27869
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2017; 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 45 YR