MAUDE Adverse Event Report: AESCULAP AG METZENBAUM SCISSORS CVD180MM; SCISSORS, GENERAL, SURGICAL

Model Number	BC606R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, they will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with a metzenbaum scissors.According to the complaint description, the scissors broke during a cesarean (c) section procedure.An additional medical intervention was necessary.An x-ray was not required, but piece retrieval was performed.There was a five minute delay.The adverse event is filed under xc reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: vigilance investigator carried out the pictorial documentation visually and microscopically.The pair of scissors were broken at the ride, directly at the thread of the screw hole.The scissors broke while riding, directly at the thread of the screw hole.The analysis of the fracture pattern shows a forced fracture due to overload.The side of fracture pattern "b" was probably the first to break, as it already showed slight signs of aging and corrosion due to reprocessing.The side of fracture "a" was probably the second to break.There are no signs of corrosion.No pores, inclusions or foreign bodies could be found at the fracture site.Batch history review: the device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.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.Explanation and rationale: according to the quality standard a material defect and production error can be excluded.There is the possibility for an usage error due to improper handling.A mechanical overload situation due to torsion or high leverage with the instrument could have led to the breakage.Conclusion and root cause: due to the current deviation and according to the information above, the root cause of the problem is the most probably usage-related.Corrective action: a capa is not necessary.
Event or Problem Description
No changes required.

• Brand Name: METZENBAUM SCISSORS CVD180MM
• Common Device Name: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12591302
• Report Number: 2916714-2021-00199
• Device Sequence Number: 11787810
• Product Code: LRW
• UDI-Device Identifier: 04038653021826
• UDI-Public: 4038653021826
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022
• Report Date (Section F): 10/07/2021

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: BC606R
• Device Catalogue Number: BC606R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2021
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 03/24/2022
• 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: Female
• Date Report Sent to FDA: 10/07/2021