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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM PLATINUM FLYER BLADE; SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. 4.0MM PLATINUM FLYER BLADE; SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72205292
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that an unusual packaging was noticed for a platinum flyer blade.Upon further inspection it was realized that sterile seal was compromised.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H10: h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Two devices from lot number 50903212 were returned for evaluation.A visual inspection found the sterile barrier on both devices were breached and the inner side of tyvek packaging had blue print.The thermoformed number on the clear plastic tray of the first device was a 2, however the second devices was a 4.Analysis of the customer provided images confirmed blue print on the inner side of the tyvek packaging.The sterile barrier was compromised.The thermoformed number on the clear plastic tray of the first device was a 2, however the second devices was a 4.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A review of the visual inspection and seal machinery process summaries confirmed the device is inspected for comprised seal integrity and abnormalities.The complaint was confirmed and the root cause was associated with manufacturing.A complaint notification has been issued to manufacturing management to mitigate future recurrences.
 
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Brand Name
4.0MM PLATINUM FLYER BLADE
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
MDR Report Key11440988
MDR Text Key238583212
Report Number1219602-2021-00455
Device Sequence Number1
Product Code HAB
UDI-Device Identifier00885556764473
UDI-Public00885556764473
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
Type of Report Initial,Followup
Report Date 03/18/2021
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 Model Number72205292
Device Catalogue Number72205292
Device Lot Number50903212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Initial Date Manufacturer Received 02/15/2021
Initial Date FDA Received03/08/2021
Supplement Dates Manufacturer Received03/15/2021
Supplement Dates FDA Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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