MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED FLEX 6.5 X 72MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72200427

Device Problem Sticking (1597)

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

Event Date 03/13/2018

Event Type  malfunction  

Event Description

It was reported that while the obturator was being removed from the cannula, it got stuck.To remove the device it was cut an insertion area which was contained with an elastomer and the device was removed it.No patient injuries or complications were reported.

Manufacturer Narrative

One 6.5 x 72mm threaded cannula was returned for evaluation.Visual examination of the device confirmed the reported breakage.The handle of the obturator has broken off from the shaft.The alignment tabs of the obturator are mis-aligned with the tab slots of the cannula.The break location shows evidence of being over torqued.The condition of the obturator indicates it was mis-aligned causing it to be subjected to excessive force /torque resulting in the breakage.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 supporting clinical/medical documents have been provided.Therefore a thorough medical investigation cannot be performed.

• Brand Name: CANNULA THREADED FLEX 6.5 X 72MM
• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7410092
• MDR Text Key: 105172275
• Report Number: 1219602-2018-00424
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1