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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN MORTON, LTD. BLADE, CARBON STEEL BLADE, SCALPEL

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SWANN MORTON, LTD. BLADE, CARBON STEEL BLADE, SCALPEL Back to Search Results
Model Number D6201
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
Root cause: the blade is supplied to deroyal by swann morton. Therefore, a supplier corrective action request (scar) was issued to swann morton. In its response, swann morton stated a root cause could not be determined due to insufficient information about how the blade came to break. Additionally, a sample was not returned for evaluation. Corrective action: a corrective action has not been taken. Investigation summary an internal complaint ((b)(4)) was received indicating a blade (part d6201, lot 3722004) broke during surgery while being used on a patient. A sample was not returned for evaluation. The purchase order was checked for discrepancies that may have contributed to the reported event. No discrepancies were identified. Seven samples were tested from deroyal inventory. No samples showed breakage when being used to cut neoprene foam. A scar was sent to the supplier, swann morton, and a response was received december 15, 2020 and accepted by deroyal personnel. In the last two years, deroyal has sold (b)(4) units of the part number in question. During the same time period, there has been one complaint, yielding a complaint-to-sales ratio of (b)(4). The investigation is complete at this time. If new and critical information becomes available, this report will be updated.
 
Event Description
The scalpel broke while being used on a patient.
 
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Brand NameBLADE, CARBON STEEL
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
SWANN MORTON, LTD.
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 Key11141195
MDR Text Key255904745
Report Number1060680-2020-00007
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD6201
Device Lot Number3722004
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
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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