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

Model Number D6201

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

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

Event Date 12/10/2020

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.

• Brand Name: BLADE, CARBON STEEL
• Type of Device: BLADE, 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 Key: 11141195
• MDR Text Key: 255904745
• Report Number: 1060680-2020-00007
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 50749756144525
• UDI-Public: 50749756144525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• 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: 3722004
• Date Manufacturer Received: 12/10/2020
• 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
• Patient Sequence Number: 1