MAUDE Adverse Event Report: AESCULAP INC. TC UTERINE SCISSORS ANGLED 265MM; DUROTIP SCISSORS

Model Number	MG211R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
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 uterine scissors angled 265mm (product # mg211r) were used during a right periacetabular osteotomy (pao), also called a bernese or ganz procedure, on (b)(6), 2023.According to the complainant, during the procedure, the scissors broke in half.Additional information revealed that a portion of the device broke off within the patient, but was able to be successfully retrieved.Although the patient reportedly spent additional time under anesthesia due to the retrieval, the length of the delay was not specified.The complaint device has been returned to the manufacturer for evaluation.The adverse event/malfunction is filed under aic reference: (b)(4).
Additional Manufacturer Narrative
Additional information: d4 serial number.During inspection of the item # (b)(4) it was confirmed the scissor had broken.The serial # on the scissor was marked with (b)(4), which tells us the scissor was shipped to aesculap on july 23, 2018.The scissor is over 4.5 years old and there is no way to determine if this was manufacturing defect or was the scissors mishandled or misused.

• Brand Name: TC UTERINE SCISSORS ANGLED 265MM
• Common Device Name: DUROTIP SCISSORS
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley, pa 18034 ; GM 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: 16675607
• Report Number: 2916714-2023-00033
• Device Sequence Number: 5282299
• Product Code: LRW
• UDI-Device Identifier: 04046964687334
• UDI-Public: 4046964687334
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: MG211R
• Device Catalogue Number: MG211R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 02/07/2024
• 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