MAUDE Adverse Event Report: CONFORMIS INC IMPACTOR HANDLE, ED-07827, CATALOG NUMBER: 1080-212; REUSABLE SURGICAL INSTRUMENT

Catalog Number	1080-212
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint reports that a screw fell out of the impactor handle, ed-07827, during surgery and landed on the floor after impacting the keel punch into the tibia.There was no impact to the surgery and there was no harm to the patient.
Additional Manufacturer Narrative
This complaint was issued august 23, 2023 regarding an impactor handle, ed-07827.The lot number, visible on the device's direct part marking, is c201001.This indicates a manufacture date of march 10, 2020.The complaint reports that a screw fell out of the impactor handle, ed-07827, during surgery and landed on the floor after impacting the keel punch into the tibia.There was no impact to the surgery and there was no harm to the patient.Pictures were provided from the complainant and the device was returned for investigation.From a visual assessment of the device, in addition to the missing screw, one of the internal locking arms was dislocated and not in the correct position (see investigation picture 2).Visually the screw threads had wear and little red loctite was visible.Upon disassembly of the device, it was evident that the locking arms of the button mechanism were broken off.It can be concluded that the cause was multifactorial.Broken components, thread wear, and lack of loctite caused the screw to fall out of the handle.The design has already been changed from a multi-component button held in place by front facing screws to a one-piece button held in place by pins fully contained within the handle.The changes were implemented on two design changes, dco-011406 and dco-012131.

• Brand Name: IMPACTOR HANDLE, ED-07827, CATALOG NUMBER: 1080-212
• Common Device Name: REUSABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): CONFORMIS INC; 600 technology park dr.; fourth floor; billerica MA 01821
• Manufacturer (Section G): CONFORMIS INC; 600 research dr; wilmington MA 01887
• Manufacturer Contact: terrance wong ; 600 technology park dr; fourth floor; billerica, MA 01821
• MDR Report Key: 17754933
• Report Number: 3004153240-2023-00028
• Device Sequence Number: 20635631
• Product Code: LXH
• UDI-Device Identifier: 00810933030582
• UDI-Public: 00810933030582
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1080-212
• Device Lot Number: C201001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Unknown