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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. BURR,5.5MM ABRADER,180MML DISPOSABLE (3 SAW, POWERED, AND ACCESSORIES Back to Search Results
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).
 
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Brand NameBURR,5.5MM ABRADER,180MML DISPOSABLE (3
Type of DeviceSAW, 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 Key7651737
MDR Text Key112885340
Report Number1219602-2018-00851
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/24/2020
Device Model Number72200082
Device Catalogue Number72200082
Device Lot Number50681538
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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