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

Model Number 72200082

Device Problem Unintended Ejection (1234)

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

Event Date 05/25/2018

Event Type  malfunction  

Event Description

It was reported that during a hip scope the burr used started spitting out blue stuff.No patient injury reported.

Manufacturer Narrative

One of two related devices was returned.Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.This complaint has no pictures.The only picture was for c-(b)(4) (affiliated complaint c-(b)(4)) 2 devices were referenced in the complaint but only one single device arrived from (b)(4) receipts on c-(b)(4).Therefore there is no picture to attach to c-(b)(4).

• 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: 7651737
• MDR Text Key: 112885340
• Report Number: 1219602-2018-00851
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010541529
• UDI-Public: (01)03596010541529(17)200224(10)50681538
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2020
• Device Model Number: 72200082
• Device Catalogue Number: 72200082
• Device Lot Number: 50681538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• 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