MAUDE Adverse Event Report: AESCULAP AG TC METZENBAUM SCISSORS CVD 180MM; GENERAL SURGICAL INSTRUMENTS

Model Number	BC263R
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information / investigation results will be provided in a supplemental report, if available.
Event or Problem Description
It was reported that there was an issue with a metzenbaum scissors cvd (180mm).The scissor came apart during a total shoulder procedure while dissecting soft tissue.The device's pin fell into the patient.The surgical staff was able to retrieve it but the device fragment was later lost in the wash.An x-ray was taken to aid in the removal of the broken piece.There was a ten minute delay in the procedure due to the reported event.The patient reportedly was not harmed during the procedure.An additional medical intervention was necessary.Additional information was not provided nor available.The adverse event / malfunction is filed under xc reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the pair of scissors are broken at the ride, directly at the thread of the screw hole.The tungsten carbide inlay is fractured near the tip.The analysis of the fracture patterns illustrates a forced fracture due to overload.The side of the fracture pattern "b" was probably the first to be fractured, as it already shows slight signs of ageing and corrosion due to reprocessing.The side of the fracture "a" was probably the second to be fractured, there are no signs of corrosion.No pores, inclusions or foreign bodies could be found on the points of rupture.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
Event or Problem Description
No updates.

• Brand Name: TC METZENBAUM SCISSORS CVD 180MM
• Common Device Name: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10960965
• Report Number: 2916714-2020-00698
• Device Sequence Number: 3150051
• Product Code: LRW
• UDI-Device Identifier: 04038653137817
• UDI-Public: 4038653137817
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/21/2021
• Report Date (Section F): 12/07/2020

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: 11/24/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 04/21/2021
• 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
• Date Report Sent to FDA: 12/07/2020