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

Catalog Number 7211020

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

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

Event Date 06/30/2015

Event Type  malfunction  

Manufacturer Narrative

Visual assessment confirmed the reported breakage.The movable jaw has broken free from the shaft.The break is angular in nature which is consistent with over torqueing.The shaft is bent and its outer sheath is deformed were the movable jaw interfaces when in the open position.Per the ifu under precautions "as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument¿s failure".No further investigation is warranted at this time.

Event Description

It was reported that during a rotator cuff repair procedure using an elite pass suture shuttle with ratchet, the jaw broke off while inside the surgical site.The broken piece was removed and the surgeon was confident that no debris remained in the surgical site.The procedure was successfully completed using a backup device.There were no patient complications reported as a result of this event.

• 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 01810 ; 5123585706
• MDR Report Key: 5975974
• MDR Text Key: 55574835
• Report Number: 1219602-2016-01087
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2015

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: T1814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 09/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• 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