MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72200829

Device Problem Break (1069)

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

Event Date 10/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

During a hip arthroscopy procedure it was reported that while using the trocar and sheath; the trocar far end broke off the rest of the instrument.The items were removed and replaced.X-ray was done cleared by the doctor.

Manufacturer Narrative

One 4mm obturator and one 6mm high flow cannula were returned for evaluation.Visual assessment of the obturator confirmed the reported breakage.The obturator is well worn and has broken where it interfaces with the handle.The device has been in use for nine years without previous issues.Visual assessment of the cannula showed the sheath is bent which is consistent with excessive forces being placed on the devices 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.Device returned to the manufacturer on (b)(6) 2016.Device was evaluated by the manufacturer.(b)(4).

• Brand Name: CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV
• 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: 5304276
• MDR Text Key: 34326069
• Report Number: 1219602-2015-01258
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

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: 72200829
• Device Lot Number: 50478700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1