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

Model Number	BC263R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the complaint device was returned to the manufacturer for evaluation.A visual examination revealed a break in the tip of the scissors.The fragment was not provided.Examination of the fracture surface revealed a fatigue fracture.No material defects, such as pores or inclusions, were identified.Traces of reprocessing were clearly visible and a gap of material removal was observed.The critical limit dimensions of 2.6 millimeters (mm) +- 0.2 mm were undercut.The actual dimension was found to be 1.8 mm.Furthermore, corrosion residues were found on the surface.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.The reported event of tip breakage was confirmed during the device evaluation.The root cause was determined to be improper maintenance performed by third party.
Event or Problem Description
It was reported to aesculap inc.That a tc metzenbaum scissors cvd 180mm (part # bc263r) were used during a should replacement procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the tip of the scissors broke off.The fragment was recovered from the patient and scans were performed to confirm that no fragments remained.The scans were negative.The complaint device was returned to the manufacturer for evaluation.Although requested, additional information has not been made available.The adverse event is filed under aic reference (b)(4).

• Brand Name: TC METZENBAUM SCISSORS CVD 180MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 14280336
• Report Number: 2916714-2022-00042
• Device Sequence Number: 6742650
• Product Code: KRO
• UDI-Device Identifier: 04038653137817
• UDI-Public: 4038653137817
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 05/03/2022
• Report Date (Section F): 05/03/2022

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: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• 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: Unknown
• Date Report Sent to FDA: 05/03/2022