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

Model Number 72203127

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/16/2017

Event Type  malfunction  

Event Description

It was reported that pieces of metal from the burr were coming off and leaving tiny shards in the patient.No patient injuries were reported.

Manufacturer Narrative

Functional inspection was performed and the inner burr did not rotate freely within the outer sheath, friction was felt in the unloaded condition.The inner burr was noted to be hitting the distal tip of the outer sheath.Galling of the inner sheath was noted opposite of the bronze bushing confirming the reported shedding.The condition of the device indicates excessive side loading took place during use causing the reported shedding.Device returned for evaluation device evaluated by the manufacturer evaluation codes updated.

• 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 w william cannon drive; austin, TX 78735
• MDR Report Key: 6821170
• MDR Text Key: 83782368
• Report Number: 1219602-2017-01031
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655899
• UDI-Public: (01)03596010655899(17)190209(10)50615075
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203127
• Device Catalogue Number: 72203127
• Device Lot Number: 50615075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• 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