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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 Metal Shedding Debris (1804)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/17/2017
Event Type  Malfunction  
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.

 
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.

 
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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 Key7172939
MDR Text Key96724158
Report Number1219602-2018-00042
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
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 Received01/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/17/2019
Device MODEL Number72200082
Device Catalogue Number72200082
Device LOT Number50664887
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/17/2017
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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