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

Catalog Number 7211020

Device Problems Break (1069); Component Falling (1105)

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

Event Date 03/02/2015

Event Type  malfunction  

Manufacturer Narrative

Visual assessment confirmed the reported breakage.The movable jaw has broken free from the shaft and the shaft is bent.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 root cause related to the manufacturing process can be established.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 top jaw broke off.The broken piece was able to be removed with a grasper.A backup device was available to complete and there were no report patient injuries or surgical complications.

• 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: 5975471
• MDR Text Key: 55783223
• Report Number: 1219602-2016-01008
• 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: 03/05/2015

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: T2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2015
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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