MAUDE Adverse Event Report: CARDINAL HEALTH SCALPEL CURITY DISPOSABLE NO. 15; SCALPEL, ONE-PIECE

Model Number	139093
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device is not available for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that during the surgical procedure, the blade from the scalpel broke in half inside the patient's knee.A larger incision needed to be made to remove the broken piece.The broken blade was removed in one piece and per protocol, an xray was taken to verify there was no product left behind.There was no harm to the patient or staff due to this broken scalpel blade.
Additional Manufacturer Narrative
No sample or photos were received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The manufacturing process was reviewed, all processes and controls were properly followed, including sub-assemblies, finished product assembly, packaging, and product inspections.Since no samples or photos of the reported problem were received, the reported condition could not be confirmed; however, the following preventive actions were taken: the production personnel received an awareness notification of the condition reported.The inspection level was increased from reduced to tighten.An awareness notification was sent to the blade supplier.Additionally, a quality alert was generated as an additional measure indicating that the operator must ensure the correct placement of the blade in the handle and assure sealing is correctly completed.The quality alert includes instructions for material segregation in case of incorrect assembly or defective material.If a sample is received at a later date, the investigation will be updated accordingly.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: SCALPEL CURITY DISPOSABLE NO. 15
• Common Device Name: SCALPEL, ONE-PIECE
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12824820
• Report Number: 9612030-2021-03094
• Device Sequence Number: 14612230
• Product Code: GDX
• UDI-Device Identifier: 10884527014521
• UDI-Public: 10884527014521
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 139093
• Device Catalogue Number: 139093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 78 KG