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

Catalog Number 72203791

Device Problems Break (1069); Misfire (2532)

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

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During a rotator cuff repair using the 72203791 truepass suture passer self-capture, it was reported that the device misfired several times while in use.The doctor suspects that there is something wrong with the trigger.Surgeon stated he had a needle tip break after hitting bone.The broken off tip was retrieved and fluoroscopy at the end of the case revealed no metal or debris left in the patient.When the device was reloaded with another needle, surgeon stated that the device was not passing suture in the cuff as it had done without issue in previous cases.He told the scrub tech to load a new needle into the passer thinking that they had a bad needle.They experienced the same results with the next needle as it wouldn't pass the suture.Several attempts were made and it still would not pass.He said the scrub tech was able to pass the needle on the back table after it wouldn't pass in the cuff however when they tried passing the suture in the cuff for a third time, it again would not pass the suture.They abandoned the device after this and completed the procedure by other means.Question was asked if they dry fired the needle prior to introducing the device into the shoulder as this may cause the needle not to deploy properly.They said that this was only done on the back table after several attempts had failed in the shoulder.Surgeon has been using the truepass since last october without issue.There was no reported delay, patient injury or surgical complication.

Manufacturer Narrative

One truepass suture passer w/self-capture mechanism was returned for evaluation.Functional assessment confirmed the device performed all designed functions.The needle picked up the suture and the self-capture mechanism captured the suture as designed.Reported complaint of mis-firing could not be confirmed or replicated.No root cause related to the manufacturing process can be established.No further investigation is warranted at this time.(b)(4).

• Brand Name: TRUEPASS
• Type of Device: TRUEPASS SUTURE PASSER, SELF-CAPTURE
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4961772
• MDR Text Key: 23458856
• Report Number: 1219602-2015-00666
• 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: Other Health Care Professional
• Type of Report: Followup
• Report Date: 07/09/2015

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
• Other Device ID Number: 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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