MAUDE Adverse Event Report: S & S SURGICAL SAFETY SCALPEL; HANDLE, SCALPEL

Model Number	D4511A
Medical Device Problem Codes	Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the root cause was determined to be lack of complete training by individuals processing the scalpels.Personnel ensured the blades were not protruding but did not verify the scalpels were in a locked position.This allowed some of the scalpels that appeared locked to maneuver open during transit.Corrective action: all applicable personnel will be reinstructed on the packaging process.Deroyal will continue to monitor reports received for the product and take additional action necessary to eliminate the issue in the future.Investigation summary: an internal complaint (b)(4) was received indicating that the blade of a safety scalpel (part d4511a, lot 48078481) was protruding when the package was opened.A sample was initially reported to be available, but this sample was not returned to deroyal for evaluation.However, a photograph of the reported defect was provided and confirmed that a blade was not secured inside the scalpel handle.Finished good inventory was checked for loose or exposed blades.No issues were found.The locking mechanisms of all the scalpels that were checked were found to be functioning correctly prior to shipping.The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The scalpel is supplied to deroyal by s & s surgical.However, the reported event was determined not to be a malfunction or defect of the scalpel but the result or an error that occurred during the packaging process.Therefore, the manufacturer was not notified of the event.Preventive action: due to the corrective action taken, a preventive action is not required at this time.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
Blade is not secure in scalpel and is sticking out.

• Brand Name: SAFETY SCALPEL
• Common Device Name: HANDLE, SCALPEL
• Manufacturer (Section D): S & S SURGICAL; 117 edgington lane; wheeling WV 26003
• MDR Report Key: 8096468
• Report Number: 2320762-2018-00011
• Device Sequence Number: 2745840
• Product Code: GDZ
• UDI-Device Identifier: 50749756645381
• UDI-Public: 50749756645381
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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
• Operator of Device: Health Professional
• Device Model Number: D4511A
• Device Lot Number: 48078481
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1