MAUDE Adverse Event Report: S&S SURGICAL PRODUCTS INC SAFETY SCALPEL, #11 500/CASE, 500/DOUBLE POLYBAG; SCALPEL, ONE-PIECE

Model Number	D4511NS-500
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributing facility reported, "blade from safety scalpel was not secured within the case.On manufacturing area 2 persons have accidentally cut their hand due the blade of k-15703-013a was not secured in place.".
Additional Manufacturer Narrative
A distributing facility reported, "blade from safety scalpel was not secured within the case.On manufacturing area 2 persons have accidentally cut their hand due the blade of k-15703-013a was not secured in place." deroyal industries requested the return of the device, however the facility stated it was not available for return.A supplier corrective action request (scar) will be sent to the scalpel manufacturer, s&s surgical products.The investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Additional Manufacturer Narrative
Deroyal industries requested the return of the device, however the facility stated it was not available for return.Deroyal performed an inventory check on 500 scalpels and reviewed 120 work orders and no issues were discovered.A complaint to sales ratio was completed between october 2021 through october 2023 and was calculated to be 0.0000017 or 0.00017%.A supplier corrective action request (scar) was sent to the scalpel manufacturer, s&s surgical products.S&s surgical inspected in process assembly and packaging and no issues were found.They also inspected inventory on hand as well as assemblying a sample lot of 20 to inspect function.No issues were found within inventory and all samples passed function testing as designed.Root cause: because the sample was not returned and no issues were identified in process inspections, no root cause could be identified.Potential root cause: it was specifically noted by s&s surgical that this issue could have occured in transit.It was also noted that warning labels are installed on all boxes due to potential issues occuring in transit.Corrective and preventive action: because no root cause could be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.The investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: SAFETY SCALPEL, #11 500/CASE, 500/DOUBLE POLYBAG
• Common Device Name: SCALPEL, ONE-PIECE
• Manufacturer (Section D): S&S SURGICAL PRODUCTS INC; 117 edgington lane; wheeling WV 26003
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19951461
• Report Number: 2320762-2023-00018
• Device Sequence Number: 8801645
• Product Code: GDX
• UDI-Device Identifier: 00749756350884
• UDI-Public: 00749756350884
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: D4511NS-500
• Device Lot Number: 58616211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Sex: Unknown