MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ABRADER BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200723

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/07/2017

Event Type  malfunction  

Event Description

It was reported that metal shavings were coming off into the joint.

Manufacturer Narrative

A visual assessment identified a significant axial fracture through the adapter body, to the outer blade.Contact points were identified on the inner burr coupled with corresponding debridement of the outer sheath.Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.The device was inspected dimensionally and found to meet design requirements.All indications point to excessive lateral load during use.Per the devices ifu ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.No further investigation is warranted at this time.

• Brand Name: DYONICS 5.5MM ELITE ABRADER BURR
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6423460
• MDR Text Key: 70769201
• Report Number: 1219602-2017-00320
• Device Sequence Number: 1
• Product Code: HAB
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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: 72200723
• Device Lot Number: 50979268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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