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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED F/R BL 4.5MM SERIES 3000 /6 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BOXED F/R BL 4.5MM SERIES 3000 /6 SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7206011
Device Problem Corroded (1131)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that the tip of the 4. 5 mm full radius bonecutter was rusted. This was noticed during set up of the shoulder arthroscopy procedure; therefore, the device was not used in the patient. A backup device was available and no significant delay was reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameBOXED F/R BL 4.5MM SERIES 3000 /6
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10991431
MDR Text Key220962136
Report Number1219602-2020-02042
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2022
Device Model Number7206011
Device Catalogue Number7206011
Device Lot Number50832042
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2019
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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