MAUDE Adverse Event Report: AESCULAP AG TC METZENBAUM SCISSORS CVD 180MM; DUROTIP SCISSORS

Model Number	BC263R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: 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 scissors cvd 180mm (item # bc263r) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the tip of the device broke off.An x-ray screening was performed to determine if the fragment detached into the patient, but nothing was found.The complaint device has been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.However, an x-ray was performed to confirm that no fragment remained in the patient.The adverse event / malfunction is filed under aic reference (b)(4).
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination revealed that deposits were present on the surface.The analysis of the fracture pattern was indicative of a force fracture due to a mechanical overload.No pores, inclusions or foreign bodies were observed at the fracture site.The device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.An investigation of the returned device confirmed the reported event of a device fracture.However, there was no indication of a material defect, manufacturing failure, or design error on the basis of the device history record.Therefore, the most probable root cause was determined to be levering or unsuitable material being processed with the device.

• Brand Name: TC METZENBAUM SCISSORS CVD 180MM
• Common Device Name: DUROTIP SCISSORS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15650820
• Report Number: 2916714-2022-00107
• Device Sequence Number: 17651459
• Product Code: LRW
• UDI-Device Identifier: 04038653137817
• UDI-Public: 4038653137817
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023
• Report Date (Section F): 10/21/2022

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: BC263R
• Device Catalogue Number: BC263R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 03/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/21/2022