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

Model Number D6201

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

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 Description

The blades are breaking, some inside patients.

Event Description

The blades are breaking, some inside patients.

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
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): SWANN MORTON, LTD.; owlerton green; sheffield, sheffield ; UK
• MDR Report Key: 11195093
• MDR Text Key: 245731341
• Report Number: 1060680-2020-00009
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 50749756144525
• UDI-Public: 50749756144525
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: D6201
• Device Lot Number: 5321812
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1