MAUDE Adverse Event Report: SWANN MORTON, LTD. CARBON STEEL BLADE #15; BLADE, SCALPEL

Model Number D6205

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating a carbon steel blade (part number d6205) broke when removing it from the scalpel handle post procedure.When it broke, the blade propelled across the or room.No injuries were reported as a result of this incident.The defective sample was discarded and not available for return.Because a lot number was not reported, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the event.The 2014-2016 supplier corrective action (scar) and supplier notification letter logs were reviewed for similar complaints.A similar complaint for the reported item was identified.A scar was issued december 2, 2017, to the device manufacturer, (b)(4).As of the date of this report, a response to the scar has not been received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

After a procedure, when removing a scalpel blade from a handle, the blade fractured and propelled across the or room.

Manufacturer Narrative

Root cause: the blade is supplied to deroyal by (b)(4).In a supplier corrective action response (scar), (b)(4) stated the true root cause of the reported issue is undetermined.The potential root cause could be, but is not limited to, end user error.As the blade was broke when it was being removed from the handle, it is possible the blade was being used on a damaged or worn handle.Corrective action: in its scar response, (b)(4) stated due to the investigation and root cause determination, a corrective action has not been taken investigation summary: an internal complaint ((b)(4)) was received indicating a carbon steel blade (part number d6205) broke when removing it from the scalpel handle post procedure.When it broke, the blade propelled across the or room.No injuries were reported as a result of this incident.The defective sample was discarded and not available for return.The customer returned a like sample for review on december 13, 2017.Because a lot number was not reported, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the event.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.A similar complaint for the reported item was identified.A scar was issued december 2, 2017, to the device manufacturer, (b)(4) and a response has been received.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

After a procedure, when removing a scalpel blade from a handle, the blade fractured and propelled across the operating room.

• Brand Name: CARBON STEEL BLADE #15
• 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: 7154139
• MDR Text Key: 96125532
• Report Number: 1060680-2017-00022
• Device Sequence Number: 1
• Product Code: GES
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D6205
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• 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