MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ELITE PASS SUTURE SHUTTLE WITH RATCHET; ACCESSORIES, ARTHROSCOPIC

Catalog Number 7211020

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

One elite-pass suture shuttle w/ratchet was returned for evaluation.A visual inspection of the device confirmed the reported breakage.The upper jaw has broken off.The tabs that interface with the shaft have broken off of the upper jaw causing the jaw to come free from the shaft.The shaft is bent downward.The condition of the device is consistent with excessive force being applied during use.No root cause related to the manufacture of the device can be established.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the tip of the elite pass suture shuttle with ratchet fell off into the patient.The piece was removed with the use of a grasper.A backup device was used to complete the procedure without further incident.No patient injury or other complications were reported.

• Brand Name: ELITE PASS SUTURE SHUTTLE WITH RATCHET
• 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: jim gonzales ; 150 minuteman road; andover, MA ; 5123585706
• MDR Report Key: 5959542
• MDR Text Key: 55377124
• Report Number: 1219602-2016-00665
• 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: 12/04/2015

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: 7211020
• Device Lot Number: 3213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1