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

Model Number	74-1010
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Eye Injury (1845); Laceration(s) (1946)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the surgical procedure when the surgeon used the knife to make the incision, the blade turned over resulting in damaging the corneal endothelium.The surgeon removed the knife and replaced with a new one.No additional injuries reported.
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and raw material components was performed and no quality issues were identified.The blades were verified to be in the handles, passed alignment inspection, and passed the pull test.The blade/knife were not returned from the end user for review.Magnified photos of the device have not been received for review.Complaints will continue to be monitored.Appropriate materials were selected to meet the design requirements.

• Brand Name: MICROSURGICALKNIVES
• Common Device Name: SHARPTOME FULL HDL - BEVEL UP
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood
• Manufacturer Contact: virnalisa cobacha ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 19762186
• Report Number: 3010692967-2024-00051
• Device Sequence Number: 8506698
• Product Code: HNN
• UDI-Device Identifier: 00848782028351
• UDI-Public: (01)00848782028351(17)260620(10)AAIA616
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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: 07/20/2026
• Device Model Number: 74-1010
• Device Lot Number: AAIA616
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2021
• 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: Other
• Patient Sex: Unknown