MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,5.5MM ABRADER,180MML DISPOSABLE (3 SAW, POWERED, AND ACCESSORIES

Model Number 72200082

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

One 72200082 disposable 5. 5mm 180mm abrader burr returned. Per the complaint, this device was used for a hip arthroscopy procedure and said: ¿upon use the product left metal shavings in the joint of the patient¿. It was noted that ¿only some shards were removed¿. The device is less than one year old. The outer diameter of the inner blade surface has skiving damage; wear band. This surface condition indicates excessive force was applied to the devices. Per 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 blade¿. No root cause related to the manufacture of the device can be established.

Event Description

It was reported that the metal parts of the burr was left in the joint of the patient. Only some shards were able to be removed from the patient.

• Brand Name: BURR,5.5MM 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7172939
• MDR Text Key: 141646616
• Report Number: 1219602-2018-00042
• 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: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/17/2019
• Device Model Number: 72200082
• Device Catalogue Number: 72200082
• Device Lot Number: 50664887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial