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

Catalog Number 72200080

Device Problem Metal Shedding Debris (1804)

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

Event Date 06/02/2017

Event Type  malfunction  

Event Description

It was reported that the burr was shedding and flaking metal into the joint.All metal shavings were removed and a backup device was available to complete the procedure with no patient impact.

Manufacturer Narrative

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.The bushing was also found to be 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.Excessive ¿side-loading¿ on the blade during use may result in wear and degradation of the inner assembly.No root cause related to the manufacture of the device can be established.Device history record review determined that no abnormalities were reported with this lot during manufacture.Use error appears to have been a contributing factor.

• Brand Name: BURR,4.0MM ABRADER,180MML DISPOSABLE (3
• 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: 6665705
• MDR Text Key: 78408153
• Report Number: 1219602-2017-00658
• Device Sequence Number: 1
• Product Code: NBH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

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 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: 06/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 06/02/2017
• Supplement Dates FDA Received: 08/01/2017
• 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