MAUDE Adverse Event Report: AESCULAP INC ADSON FORCEPS TC 120MM 1 X 2 TEETH; BASIC INSTRUMENTS

Model Number	US109
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, a supplement will be submitted.
Event or Problem Description
It was reported that there was an issue with an adson forceps.The carbide insert on the device broke into pieces and fell into the patient.The surgeon was able to remove the pieces which caused a delay (less than five minutes).All pieces were visible with and easily retrieved.An alternative device from the set (another pattern) was readily available and used to complete the procedure.An additional medical intervention was necessary.The patient was noted to be stable.Additional patient information is not available.The adverse event is filed under reference (b)(4).
Additional Manufacturer Narrative
If additional information or investigation results become available, a supplement will be submitted.
Event or Problem Description
Additional information was received via receipt of mw 5097029: the teeth portion on the adson forceps separated and came off; this occurred when making the initial incision.
Additional Manufacturer Narrative
Investigation problem description tc 1 - tooth side - completely missing tc 2- tooth side - partially missing visual inspection stains, scratches and signs of use were visible on the surface.The markings were very pale but toothing was intact.Batch review some batches were partially reworked due to pores in the solder.These pores were only a visual defect and not the cause of the tc fracture.Analysis of root cause the condition of the forceps suggests that they were in regular to frequent use.Possible causes for the tc leaflet falling off may be mechanical impact and/or incorrect reprocessing in conjunction with exceeding the service life.Due to the missing lot number and information on reprocessing, a well-founded analysis as well as traceability is not possible.Although the failure mode was confirmed, a manufacturing or design related issue was not found.

• Brand Name: ADSON FORCEPS TC 120MM 1 X 2 TEETH
• Common Device Name: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 10726678
• Report Number: 2916714-2020-00575
• Device Sequence Number: 11192730
• Product Code: HTD
• UDI-Device Identifier: 04046955076949
• UDI-Public: 4046955076949
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021
• Report Date (Section F): 10/23/2020

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: US109
• Device Catalogue Number: US109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/19/2020; 08/10/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/13/2020; 09/01/2021
• 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: 10/23/2020