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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN-MORTON LIMITED CARBON STEEL BLADE, #15 BLADE, SCALPEL

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SWANN-MORTON LIMITED CARBON STEEL BLADE, #15 BLADE, SCALPEL Back to Search Results
Model Number D6205
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/25/2017
Event Type  malfunction  
Manufacturer Narrative
Root cause: the blade is supplied to deroyal by swann-morton. In a supplier corrective action response (scar), swann-morton stated the true root cause of the reported issue is undetermined. The potential root cause could be, but is not limited to, end user error. The design of the blade is for cutting soft tissue, and if the blade was used in or around bone with the use of excessive lateral pressure, this could contribute to the blade breaking. If the blade gets damaged in anyway with the use of forceps while being attached to the handle prior to use, this could also weaken the blade. Corrective action: in its scar response, swann-morton stated due to the investigation and root cause determination, a corrective action has not been taken. An internal complaint (b)(4) was received indicating a carbon steel blade (part number d6205) broke inside a patient during a procedure. An additional procedure was required to remove the device fragment. The defective sample was discarded and not available for return. The customer returned a like sample for review on (b)(6) 2017. Because a lot number was not reported, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the event. The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints. A similar complaint for the reported item was identified. A scar was issued (b)(6) 2017, to the device manufacturer, swann-morton and a response has been received. Preventive action: due to the investigation and root cause determination, a preventive action has not been taken. The investigation is complete at this time. If new and critical information is received, this report will be updated.
 
Event Description
A scalpel fractured inside a patient's foot during surgery and required fluoroscopy to locate.
 
Manufacturer Narrative
Investigation summary: an internal complaint (call (b)(4)) was received indicating a carbon steel blade (part number d6205) broke inside a patient during a procedure. An additional procedure was required to remove the device fragment. The defective sample was discarded and not available for return. Because a lot number was not reported, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the event. The 2014-2016 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints. A similar complaint for the reported item was identified. A scar was issued (b)(6) 2017, to the device manufacturer, swann-morton. As of the date of this report, a response to the scar has not been received. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
 
Event Description
A scalpel fractured inside a patient's foot during surgery and required fluoroscopy to locate.
 
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Brand NameCARBON STEEL BLADE, #15
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
SWANN-MORTON LIMITED
owlerton green
sheffield, sheffield
UK
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1703 highway 33 south
new tazewell TN 37825
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key7156715
MDR Text Key269522295
Report Number1060680-2017-00021
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD6205
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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