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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER 4.5MM PLATINUM; SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72202531
Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2020
Event Type  malfunction  
Event Description
It was reported that during setup when the package was open surgeon found that the tip of the bonecutter was dirty.The procedure was completed with a backup device and no delay or complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device shows wear from use on the outer surface of the inner blade and the chamber has biological debris in it.The tip has biological debris and shows wear from use.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include contact with foreign substances after opening the package.No containment or corrective actions are recommended at this time.
 
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Brand Name
FULL RADIUS BONECUTTER 4.5MM PLATINUM
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 Key10514941
MDR Text Key206350190
Report Number1219602-2020-01378
Device Sequence Number1
Product Code HAB
UDI-Device Identifier00885554027891
UDI-Public00885554027891
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,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/29/2023
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 Expiration Date12/06/2021
Device Model Number72202531
Device Catalogue Number72202531
Device Lot Number50810050
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/20/2020
Initial Date FDA Received09/10/2020
Supplement Dates Manufacturer Received10/25/2023
Supplement Dates FDA Received10/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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