MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203127

Device Problem Metal Shedding Debris (1804)

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

Event Date 02/08/2018

Event Type  malfunction  

Event Description

It was reported that during a hip arthroscopic procedure, the surgeon has noted that the metal debris has been left in the hip after using the 5.5 high vis bur.The surgeon noted that the patient had a larger body habitus and more leverage placed on the shaver blade to gain access to the area of concern.The surgeon lavage and use of soft tissue shaver blade to remove as much debris as possible.No patient injury was reported.

Manufacturer Narrative

Examination is not possible, as the device will not be returned.Review of the clinical details provided reported the patient had a larger body habitus and more leverage was placed on the shaver blade to gain access to the area of concern.

• Brand Name: BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.
• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7281022
• MDR Text Key: 100555621
• Report Number: 1219602-2018-00236
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• 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