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

Model Number CARBON STERILE SURGICAL BLADE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The handle manufacturer to which the blade was attached is not available for inspection and the quality or brand of this handle is unknown and no products were returned for the manufacturer to carry out an investigation.The only information that we have received is a lot number.Images of the broken blades following use were received but we could not identify whether these were related to the lot number in question (5321812).No action can be taken as no samples have been made available.Following manufacturer's requests, no further information has been provided by the customer in order to carry out further investigation.As no samples were received an investigation can only be conducted on production records using the lot numbers provided.The following description has been sent to the customer.Investigation/report: thank you for bringing to our attention your customer's complaint.It states on this lot number there have been multiple reports of our carbon sterile sm blades breaking, some inside patients.We are aware this is now your third customer complaint of this nature from this product, this one being a different lot number from the previous two through email correspondence with deroyal, we have now been informed that the amount of broken blades reported is three and not eight as stated in the report.We are taking these broken blades complaints very seriously and as such this once again falls into the category of an adverse incident and must be reported to the competent authority mhra and fda.With this being an adverse incident, it is paramount to our investigation that we receive samples to test and as much information, including the surgical procedure as possible.At this stage, we are very limited to the information we can provide due to us receiving only two photographs, these being the same pictures that were supplied with the previous complaint.The photograph is the embossed information on the top of the packet is of the lot number of the previous complaint.Using the lot number from the complaint report we can confirm that we have received no further customer complaints regarding broken blades from this product, of which 445,300 carbon sterile sm10 blades were produced and sold on this lot number.Once again if samples and further information were to become available and returned we would be able to perform a further investigation and provide you with an additional report.If you require any more assistance, please do not hesitate to contact us further.Root cause: the root cause of this complaint could not be determined as we have received very limited information including the surgical procedure that was being performed at the time of breakage and also no samples to perform an investigation on.Could it be possible that the blades could have become fractured or broken whilst they have been fitted or removed from the handle?.

Event Description

The customer's only communicated information was included in a scar document ((b)(4)) sent to the distributor as follows 'multiple reports of blades breaking, some inside patients.' swann-morton contacted the distributor further in the attempt to gather more information; however, no further information was provided by the customer.No samples have been returned for investigation purposes and no information regarding the procedures being performed at the time of breakage.

• Brand Name: SWANN-MORTON
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON, LTD.; owlerton green; sheffield, gb ; UK
• Manufacturer (Section G): SWANN-MORTON, LTD.; owlerton green; sheffield, gb ; UK
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 11217588
• MDR Text Key: 242404027
• Report Number: 9611194-2021-00002
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2021

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: CARBON STERILE SURGICAL BLADE
• Device Catalogue Number: 0201
• Device Lot Number: 5321812
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 01/22/2021
• 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
• Patient Outcome(s): Other