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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 5.5MM SER 3000 SAW, POWERED, AND ACCESSORIES
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SMITH & NEPHEW, INC. FULL RADIUS BLADE 5.5MM SER 3000 SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7206010
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 09/17/2020
Event Type  Injury  
Event Description

It was reported that during a shoulder scope surgery, when the surgeon started to use the blade, it dropped metal in the shoulder. Additionally, it was stated that the blade was being used on soft tissue, no bone work. Another blade was used to complete the surgery and to remove all metal pieces. No significant delay or other complications 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 NameFULL RADIUS BLADE 5.5MM SER 3000
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 Key10656153
MDR Text Key210626028
Report Number1219602-2020-01550
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7206010
Device Catalogue Number7206010
Device LOT Number50854319
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 Received09/17/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/31/2020
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: 10/09/2020 Patient Sequence Number: 1
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