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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN-MORTON LTD SWANN MORTON SCALPEL BLADE

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SWANN-MORTON LTD SWANN MORTON SCALPEL BLADE Back to Search Results
Model Number 0201
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2018
Event Type  malfunction  
Manufacturer Narrative
Response provided to the customer: thank you for informing us of your most recent complaint where the end user states that one of our carbon sterile sm10 and sm15 blades broke during use, also thank you for following up with further information, this allows us to try and understand how the blades actually broke. Having received no lot number for either of the two blade shapes it makes it very difficult for us to check through our production records to see if there are any recorded problems. We are also unable to check if we have received any further complaints of a similar nature from these two batches of blades. Having received no samples of the two broken blades or any from the same shelf box we are unable to perform our usual checks that would consist of the heat treatment hardness and the ductility tests. We therefore can only assume with the blade being used in and around the hip joint, twisting or excessive lateral pressure could have been applied in or around the bone causing the blades to break. We apologise that at this stage we are unable to give you any more clarity into this complaint due not having any samples returned or lot numbers provided. If samples and lot numbers were to become available we would be able to perform a more thorough investigation and issue you with a more detailed report. If in the meantime we can be of any further assistance please do not hesitate to contact us.
 
Event Description
Description given by healthcare facility: "number blades (#10 and #15) broke". Initially, this was the only information we received from the customer. Following subsequent communications, it was identified that the procedure being performed at the time of breakage was a total joint, hip procedure.
 
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Brand NameSWANN MORTON
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
SWANN-MORTON LTD
penn works owlerton green
sheffield, S6 2B J
UK S6 2BJ
Manufacturer (Section G)
SWANN-MORTON LTD
penn works owlerton green
sheffield, S6 2B J
UK S6 2BJ
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key7925147
MDR Text Key122641695
Report Number9611194-2018-00005
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0201
Device Catalogue Number0201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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