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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER 2.9 MAG-MINI DISP. BLADE; SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. ABRADER 2.9 MAG-MINI DISP. BLADE; SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72201518
Device Problems Material Fragmentation (1261); Material Separation (1562)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2020
Event Type  Injury  
Event Description
It was reported that, during a wrist arthroscopic surgery using a "2.9mm abrader blade", metal pieces were found while removing the sclerotic bone.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Event Description
It was reported that, during a wrist arthroscopic surgery using a "2.9mm abrader blade", metal pieces were found while removing the sclerotic bone.The metallic pieces were successfully removed from the patient.The pieces were removed using tweezers and suction.The procedure was completed using a back-up device.It is unknown if there was a delay.No other complications were reported.
 
Manufacturer Narrative
H10: b5: event description updated.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
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Brand Name
ABRADER 2.9 MAG-MINI DISP. BLADE
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
MDR Report Key10558141
MDR Text Key207689391
Report Number1219602-2020-01436
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010621672
UDI-Public03596010621672
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/10/2022
Device Model Number72201518
Device Catalogue Number72201518
Device Lot Number50832090
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/27/2020
Initial Date FDA Received09/20/2020
Supplement Dates Manufacturer Received09/17/2020
06/02/2021
Supplement Dates FDA Received09/24/2020
06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age23 YR
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