MAUDE Adverse Event Report: SWANN-MORTON LTD SINGLE USE SCALPEL BLADE

Model Number 0205

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2018

Event Type  malfunction  

Event Description

Description given by the healthcare facility: "the 15 blade broke off in a patient.This was from the extremity pack." no further information was given.We have contacted the customer to provide more information if available.

Event Description

At the time of the complaint the healthcare facility were not able to locate any samples to perform tests on so we submitted our reports accordingly to meet the reporting timescales.We had communication from the customer last week that they had located some samples and had returned them.As a result of this we performed an investigation on the returned samples and issued a follow up report to the customer: regarding your complaint that we first received from you in april 2018, at the time of this complaint, we feel that we answered it to the best of our ability due to no samples being returned for us to test.Having now received several unopened samples from the same lot number we were able to perform the required tests.We first tested the blades by putting them on our calibrated vickers hardness testing machine, where we found all returned blade were all reading above 800 vickers indicating that they have been made to the surgical blade standard bs 2982.We also subjected the blades to a ductility test on our automated load cell, where we found all blades to be within our in house tolerance.We therefore cannot understand how the surgeon managed to break the blades unless excessive lateral pressure or twisting was applied in or around bone.If you require further assistance, please do not hesitate to contact us.

• Brand Name: SINGLE USE SCALPEL BLADE
• Type of Device: SINGLE USE SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON LTD; penn works owlerton green; sheffield, S6 2B J; UK S6 2BJ
• MDR Report Key: 7541917
• MDR Text Key: 109628757
• Report Number: 9611194-2018-00001
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

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: Physician
• Device Model Number: 0205
• Device Catalogue Number: 0205
• Device Lot Number: 4771710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention