MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; SHARPTOME FULL HDL - BEVEL UP

Model Number	74-1010
Health Effect - Clinical Codes	Bacterial Infection (1735); Itching Sensation (1943)
Date of Event	11/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, during the surgery, there was deformation of the blade, the patient''s eyes were itchy after surgery, and there was infection.The patient required a second surgery to remedy the infection due to damage to the external tissues, and the subsequent surgery was successful, and the patient status was stable.Adrs report code (b)(4).
Additional Manufacturer Narrative
The device history records, sterility records were reviewed.No nonconforming results were identified.No issues were noted throughout the incoming inspection of components/raw materials, manufacturing, in-process or final inspection processes.No samples or photos were returned for review.A retained sample was available for evaluation.The blade met all current visual requirements.No damage or abnormalities were identified.It was reported the blade was damaged or deformed.It is not clear why the device was utilized for the surgery with the damage reported.The patient presented with itchy eyes, damaged tissue and required a 2nd procedure which was successful.The patient was reported as stable.A report of a dull blade / knife or bent tip occurring during a procedure can be the result of a damaged cutting edge, point or apex on the blade.Damage to the knife / blade has occurred when removing the knife from the protective foam, package or while preparing the knife for the procedure.The blade component edges and points can be damaged very easily if dropped, bumped or come in contact with any hard, rough surface.Without received the actual defective device, receiving sterile samples from the same lot to review/test, receiving photos of the actual defective device or receiving detailed information regarding the method utilized to remove the device from the packaging, preoperative preparation of the device, procedure performed, identification of the infection/culture results, details of the damaged tissue or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• Brand Name: SHARPOINT
• Common Device Name: SHARPTOME FULL HDL - BEVEL UP
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 15947839
• Report Number: 3010692967-2022-00057
• Device Sequence Number: 7341279
• Product Code: HNN
• UDI-Device Identifier: 10848782028358
• UDI-Public: (01)10848782028358(17)260502(10)AAHT903
• Combination Product (Y/N): N
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2022
• Report Date (Section F): 12/05/2022

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 Expiration Date: 05/02/2026
• Device Model Number: 74-1010
• Device Catalogue Number: 74-1010
• Device Lot Number: AAHT903
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2022
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2021
• 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: Required Intervention
• Patient Sex: Female