MAUDE Adverse Event Report: SWANN MORTON, LTD. CARBON STEEL BLADE; 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	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ( (b)(4)) was received regarding a scalpel (part d6201, lot 5321812) breaking during use.The investigation is ongoing at this time.When new and critical information becomes available, the report will be updated.
Event or Problem Description
The blades are breaking, some inside patients.
Event or Problem Description
The blades are breaking, some inside patients.
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.According to swann morton's response, the root cause could not be determined as limited information has been received, including the surgical procedure being performed at the time of breakage.Also, no samples were returned to evaluate.Corrective action: a corrective action has not been taken.Investigation summary: an internal complaint ((b)(4)) was received regarding a scalpel (part d6201, lot 5321812) breaking during use.A sample was not returned for evaluation.However, a photo of the affected blade was provided and showed the blade was snapped.No information was received about the type of handle the end user was using with the blade at the time the break occurred.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.Inventory was checked and passed with no breaks occurring.The product is supplied to deroyal by swawnn morton.Therefore, a scar was issued to swann morton.A response was received january 22, 2021 and accepted by deroyal personnel.The investigation is complete at this time.If new and critical information becomes available, the report will be updated.

• Brand Name: CARBON STEEL BLADE
• Common Device Name: BLADE, SCALPEL
• Manufacturer (Section D): SWANN MORTON, LTD.; owlerton green; sheffield, sheffield ; UK
• MDR Report Key: 11195093
• Report Number: 1060680-2020-00009
• Device Sequence Number: 3940614
• 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,Followup
• Report Date (Section B): 02/02/2021

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: 5321812
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1