MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,4.0MM ABRADER,180MML DISPOSABLE (3; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200080

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device investigation narrative - one used 4.0 x 180 mm abrader burr was returned for evaluation.Visual assessment showed the adapter body is cracked at the base of the outer tube.Visual assessment of the inner burr showed visible signs of material galling and debridement confirming the reported shedding.The bushing is also scored.Functional inspection was performed and the inner burr rotated freely within the outer sheath, no friction was felt.The condition of the burr indicates an excessive lateral load was applied 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 root cause related to the manufacture of the device can be established.No further investigation is warranted at this time.(b)(4).

Event Description

It was reported that the burrs were shedding and flaking.Debris was removed from the patient.A backup device was available to complete the procedure.No patient impact was reported.

• Brand Name: BURR,4.0MM ABRADER,180MML DISPOSABLE (3
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6683947
• MDR Text Key: 78925357
• Report Number: 1219602-2017-00678
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 72200080
• Device Lot Number: 50644736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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