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

Model Number	D6201
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The scalpel broke while being used on a patient.

• Brand Name: BLADE, CARBON STEEL
• Common Device Name: BLADE, SCALPEL
• Manufacturer (Section D): SWANN MORTON, LTD.; owlerton green; sheffield, sheffield ; UK
• MDR Report Key: 11141195
• Report Number: 1060680-2020-00007
• Device Sequence Number: 4043102
• Product Code: GES
• UDI-Device Identifier: 50749756144525
• UDI-Public: 50749756144525
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: D6201
• Device Lot Number: 3722004
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1