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

Catalog Number 72203791

Device Problem Misfire (2532)

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

Event Type  malfunction  

Manufacturer Narrative

The date of the actual event is unknown.One device was returned for evaluation.Due to the nature of the reported complaint, a visual and dimensional evaluation was not required.The device was functionally evaluated and confirmed to perform as intended.The device was able to successfully pass suture through a simulated rotator cuff.The reported failure mode was able to be replicated.The issue was able to be resolved by performing a second actuation of the needle.It was also identified that fully loading the suture into the back of the channel, and compression of the rear handle in conjunction with the ratchet release button at the same time will improve the ease of the ratchet release.The root cause can be attributed to improper technique.As a result additional information regarding the above steps will be added to the training guide.(b)(4).

Event Description

During research and development limited market release review of the truepass device, it was reported that a customer experienced issues with the use of the device.It was reported that the device was misfiring and there was difficulty releasing the ratchet.The surgeon completed the procedure using a competitors device.There was a reported delay of 5 minutes.It was confirmed that nothing broke off in the patient.There was no patient complications or injuries reported.

• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5224217
• MDR Text Key: 31448884
• Report Number: 1219602-2015-01158
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/23/2013

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: 20810
• Other Device ID Number: 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 11/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1