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

Model Number BC263R

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with bc263r - tc metzenbaum scissors cvd 180mm according to the complaint description, it was reported that on (b)(6) 2020 the tc metzenbaum scissors cvd 180mm 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./ this event/malfunction prolonged the surgery for 10 minutes.Additional information was not provided nor available / was not available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

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.

• Brand Name: TC METZENBAUM SCISSORS CVD 180MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10961033
• MDR Text Key: 220690396
• Report Number: 9610612-2020-00868
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC263R
• Device Catalogue Number: BC263R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention