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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 Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/15/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that during an arthroscopy procedure, a part of the tip of the inner bonecutter blade was peeled off. The procedure was successfully completed using a back-up device. It is unknown if there was a delay. It is unknown if the peel part was removed from the patient.
 
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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 Key12297770
MDR Text Key265780161
Report Number1219602-2021-01684
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7206011
Device Catalogue Number7206011
Device Lot Number50915094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/09/2021 Patient Sequence Number: 1
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