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 Foreign Body In Patient (2687)

Event Date 12/05/2014

Event Type  malfunction  

Manufacturer Narrative

Visual assessment 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.Per the devices ifu under ¿precautions¿ ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.¿ no root cause related to the manufacture of the device can be established.No further investigation is required at this time.

Event Description

It was reported that during a hip arthroscopy procedure using an elite pass suture shuttle with ratchet, it was reported that the top jaw snapped off while inside the patient.The broken piece was retrieved with graspers.A backup device was available to complete the procedure.There were no reported patient injuries or 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: 5975311
• MDR Text Key: 55897343
• Report Number: 1219602-2016-01002
• 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: 12/08/2014

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: 7211020
• Device Lot Number: T114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• 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