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

Catalog Number 72203791

Device Problems Break (1069); Failure to Capture (1081)

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

Event Date 05/05/2014

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated for the reported complaint mode ¿window broke.¿ the complaint was confirmed.The root cause has been determined to be a burr on the end of the proximal arm of the torsion spring.This burr occurs during the manufacture of the spring as it is cut and can extend beyond the profile of the jaw once assembled.The damage to the window (trap door) was most likely caused by the device catching on the cannula during withdrawal from the joint.The proximal arm is bent 180o distally and was forced up against the trapdoor; becoming permanently damaged.No other complaints for this lot.(b)(4).

Event Description

During a rotator cuff repair using the truepass suture passer, self-capture it was reported that the capture window broke during procedure.It was reported that the device would not capture the suture.The device has been cleaned by steam.It was confirmed that nothing broke in the patient.The sales representative was present at the case.One suture had been passed.The surgeon went back down the 6.5 cannula to continue.The damage wasn't realized until an attempt was made to pass suture and it wouldn't capture or pass.There may have been incidental pressure while within the cannula, engaging the teeth and bending the coil.It was reported that a competitor's device was available to complete the procedure.

• 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: 5009877
• MDR Text Key: 24536403
• Report Number: 1219602-2015-00837
• 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
• Report Date: 05/12/2014

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: 22755
• Other Device ID Number: 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2014
• 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