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

Model Number 0201

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

Response provided to the customer: thank you for informing us of your most recent complaint where the end user states that one of our carbon sterile sm10 and sm15 blades broke during use, also thank you for following up with further information, this allows us to try and understand how the blades actually broke.Having received no lot number for either of the two blade shapes it makes it very difficult for us to check through our production records to see if there are any recorded problems.We are also unable to check if we have received any further complaints of a similar nature from these two batches of blades.Having received no samples of the two broken blades or any from the same shelf box we are unable to perform our usual checks that would consist of the heat treatment hardness and the ductility tests.We therefore can only assume with the blade being used in and around the hip joint, twisting or excessive lateral pressure could have been applied in or around the bone causing the blades to break.We apologise that at this stage we are unable to give you any more clarity into this complaint due not having any samples returned or lot numbers provided.If samples and lot numbers were to become available we would be able to perform a more thorough investigation and issue you with a more detailed report.If in the meantime we can be of any further assistance please do not hesitate to contact us.

Event Description

Description given by healthcare facility: "number blades (#10 and #15) broke".Initially, this was the only information we received from the customer.Following subsequent communications, it was identified that the procedure being performed at the time of breakage was a total joint, hip procedure.

• Brand Name: SWANN MORTON
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON LTD; penn works owlerton green; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN-MORTON LTD; penn works owlerton green; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 7925147
• MDR Text Key: 122641695
• Report Number: 9611194-2018-00005
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0201
• Device Catalogue Number: 0201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 81