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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
Catalog Number 72200082
Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2017
Event Type  malfunction  
Manufacturer Narrative
Examination was not possible, as the device was not returned. The investigation was limited to the information provided and no relevant clinical information was received to assist in the evaluation. The investigation could not draw any conclusions about the reported event with the clinical details provided. A review of the device history record was performed which confirmed no inconsistencies. No further investigation is warranted at this time.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the burr was shedding during osteoplasty. A back up device was reported to be available to complete the procedure. A delay was reported that was less than 30-minutes with no patient impact.
 
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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
james gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key6649335
MDR Text Key141591695
Report Number1219602-2017-00611
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 08/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2019
Device Catalogue Number72200082
Device Lot Number50647251
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2017
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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