MAUDE Adverse Event Report: AESCULAP INC. TC METZENBAUM SCISS DEL CVD S/S 145MM; DUROTIP SCISSORS

Model Number	MB207R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a tc metzenbaum sciss del cvd s/s 145mm (part # mb207r) was used during a procedure on (b)(6) 2023.According to the complainant the tip of the device had broken off during use.Reportedly the tip was retrieved and the procedure was successfully completed with a different instrument.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Additional information: h6 codes updated investigation results: one (1) sample provided was sent to the manufacturing site for evaluation and the results of the investigation confirmed that the tip had broken off.Heat treated delicate instruments such as the tc metzenbaum sciss del cvd s/s 145mm are very hard, but that hardness makes them brittle.This has made the instrument vulnerable to strikes, such as when the instrument was dropped, or if something was dropped on them.Based on the investigation findings, the exact root cause of the break was unable to be determined.The manufacturing site is aware of this issue and has entered this complaint into our trending report.There were no other reported similar events of this nature.Although this event is believed to be an isolated incident, the quality control team has been directed to scrutinize each new pair of scissors to attempt to identify if any new trending concerns exist.Quality control employees were re-trained on the importance of identifying and escalating any concerns associated with the device during inspection and trending reviews.

• Brand Name: TC METZENBAUM SCISS DEL CVD S/S 145MM
• Common Device Name: DUROTIP SCISSORS
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 18162934
• Report Number: 2916714-2023-00121
• Device Sequence Number: 6503490
• Product Code: GEN
• UDI-Device Identifier: 04046964683688
• UDI-Public: 4046964683688
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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 Model Number: MB207R
• Device Catalogue Number: MB207R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown