MAUDE Adverse Event Report: SWANN MORTON LTD. SWANN-MORTON NO. 10 CARBON STERILE BLADES; SCALPEL BLADE

Model Number NO. 10 CARBON STERILE BLADES

Device Problem Break (1069)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

Please see below the description provided by the healthcare facility, "the blade tip broke in half inside of the incision.It was reported that both pieces of the blade were retrieved.No injuries reported.Unfortunately the customer did not return the blade in this incident to us".The healthcare facility did not provide a description of any remedial action however, stated that injuries were reported and the pieces of the device that had broken had been retrieved.

Manufacturer Narrative

Please find below the response sent to the customer: "thank you for bringing your customer's complaint to our attention.It states that the tip of a carbon sterile sm10 blade broke inside the incision during an anterior hip procedure.With this blade breaking during a procedure, we are obligated to report this to the relevant competent authorities as it falls into the category of an adverse incident.Unfortunately, it does state that no samples are currently available for us to investigate.As you are aware, for us to be able to perform a thorough investigation, we do require the blade in question returned or blades from the same shelf box or lot number to test.With you providing us with the lot number, we have been able to check our in-process records and we have been unable to identify any problems that could assist us with our investigation.We have also checked our history and we can inform you that we have received no further customer complaints of this nature of which 430,100 carbon sterile sm10 blades were produced and sold.The only explanation we can offer at this stage is with this blade breaking during a hip procedure, if there was any excessive twisting or lateral pressure applied whilst being used in or around the bone, this could have caused the tip of the blade to break.If the blade in question or samples from the same shelf box or lot number does become available and can be returned, we would then be able to perform the relevant tests and issue you with a further report detailing our findings.If we can be of any further assistance, please do not hesitate to contact us.The root cause of this broken blade could not be established as we have not received the broken blade in question or blades from the same shelf box or lot number to test.The only explanation we can offer is the one mentioned above.No corrective action is required as we have been unable to establish the root cause of this broken blade.No preventive action is required as we have been unable to establish the root cause of this broken blade.".

• Brand Name: SWANN-MORTON NO. 10 CARBON STERILE BLADES
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN MORTON LTD.; owlerton green; sheffield, , gb S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN MORTON LTD.; owlerton green; sheffield, , gb S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 16796743
• MDR Text Key: 313841555
• Report Number: 9611194-2023-00002
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 05033955002015
• UDI-Public: 05033955002015
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2023

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: NO. 10 CARBON STERILE BLADES
• Device Catalogue Number: 0201
• Device Lot Number: 5092110
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/24/2023
• 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