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

Model Number 7211021

Device Problems Break (1069); Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 04/16/2014

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair, the hinge did not hold tight as the suture was being passed.After it was out and being inspected by the surgeon, the top part of the jaws broke off entirely.The patient was not injured.Nothing broke off in the patient.It was reported that surgery time was extended by 2 hours.There was no back up device.We used disposable accu-pass passers to complete the surgery.

Manufacturer Narrative

Device expiration date unavailable at this time.The elite pass suture shuttle w/o ratchet device was received for evaluation and the complaint mode was visually confirmed.The upper jaw was also returned and both of the holding tabs were missing, causing the jaw to disengage.The broken upper jaw also exhibited damage from a torsional overload.The device had been twisted while engaged.No root cause related to manufacturing can be established.No further action is required.No other complaints for this lot.(b)(4).

• Brand Name: ELITE PASS SUTURE SHUTTLE W/O 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4956967
• MDR Text Key: 6194256
• Report Number: 1219602-2015-00639
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211021
• Device Lot Number: LT713
• Other Device ID Number: 8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention