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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM FULL RADIUS PLATINUM SERIES SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. 4.5MM FULL RADIUS PLATINUM SERIES SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72203521
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/08/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during a knee arthroscopy, the full radius platinum series blade was leaving a black residue on the femoral condyle that looked like metal debris and was not possible to be removed. The procedure was successfully completed with non-significant delay using a back-up device. No other complications were reported.
 
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Brand Name4.5MM FULL RADIUS PLATINUM SERIES
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 Key12550764
MDR Text Key273995141
Report Number1219602-2021-02169
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72203521
Device Catalogue Number72203521
Device Lot Number50920994
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2021
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: 09/29/2021 Patient Sequence Number: 1
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