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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR BLADE 4.5 DSPL EP-1(BX6); SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. INCISOR BLADE 4.5 DSPL EP-1(BX6); SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205313
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2024
Event Type  malfunction  
Event Description
It was reported that during an lca procedure , the incisor blade broke.The broken device was removed from the patient.The procedure was completed using a back-up device.There was a delay of 5 minutes and no further complications were reported.
 
Manufacturer Narrative
H10: internal complaint reference: (b)(4).
 
Manufacturer Narrative
H10: internal complaint reference (b)(4).H6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
 
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Brand Name
INCISOR BLADE 4.5 DSPL EP-1(BX6)
Type of Device
SAW, 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 Key18908639
MDR Text Key337710856
Report Number1219602-2024-00499
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010251411
UDI-Public03596010251411
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7205313
Device Lot Number51111711
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/14/2024
Supplement Dates Manufacturer Received04/19/2024
Supplement Dates FDA Received04/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age26 YR
Patient SexMale
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