MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIGH FLOW CANNULA, DIAGNOSTIC 6MM ROTATABLE DOUBLE VALVE; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72200829

Device Problem Device Inoperable (1663)

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

Event Date 04/15/2013

Event Type  Injury  

Event Description

During an unknown procedure utilizing the high flow cannula, diagnostic 6mm rotatable double valve, it was reported that the scope lens cannot reach out from the cannula so as to affect the surgery view.There was not a backup device available, and it was reported that the surgeon was required to go into the articular cavity directly by scope.There was a two (2) hour extension of the surgery.It is stated that the surgeon completed the procedure by scope without cannula.(b)(4).

Manufacturer Narrative

Subject device was returned for evaluation.Visual assessment shows a notable gap between the rotating ring, compression sleeve and female body adaptor.Disassembly of the device showed that an incorrect sized quad ring was present.It is stated that this condition would cause the reported complaint.It was confirmed that the incorrect sized quad ring was not used during the manufacture of the subject device.Review of sap records do not show that the device was returned for repair.Investigation states that the subject device has the appearance of being repaired by an unauthorized third party.A review of the device history report(s) did not identify any discrepancies.A review of the complaint history confirmed that no additional complaints were associated with the manufactured lot on file.Per results of the investigation, the root cause was determined to be ¿improper maintenance¿.At this time, no further investigation will be implemented.

• Brand Name: HIGH FLOW CANNULA, DIAGNOSTIC 6MM ROTATABLE DOUBLE VALVE
• 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: 4939231
• MDR Text Key: 6040261
• Report Number: 1219602-2015-00451
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200829
• Device Lot Number: 50364028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention