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

Catalog Number 72203791

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 08/06/2019

Event Type  malfunction  

Event Description

It was reported that during a shoulder cuff repair surgery,the front end of the product was stuck.There was a surgical delay greater than 30 minutes.A backup device was available to complete the procedure with no patient injuries.

Manufacturer Narrative

The reported truepass suture passer w/self-capture feature intended for use in treatment, has been returned for evaluation.Visual assessment of the device confirmed the torsional spring is bent and dislodged from the recessed grooves.This condition would result in the suture not being able to be picked up by the self-capture feature.The condition of the device indicates it was roughly handled causing the bending of the spring.Per the device instruction for use ¿the grasping jaw of the truepass suture passer, including the self-capture feature, is delicate and can be damaged if handled roughly.Do not drop the instrument from any height.Keep the grasping jaw closed when not in use.Do not manually open the self-capture feature while cleaning, as extension beyond 90 can permanently damage the device¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TRUEPASS SUTURE PASSER SELF-CAPTURE
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8923325
• MDR Text Key: 155327051
• Report Number: 1219602-2019-01005
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885554030419
• UDI-Public: 00885554030419
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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: 46741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR