MAUDE Adverse Event Report: CONFORMIS IMPACTOR HANDLE REUSABLE INSTRUMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	1080-212
Medical Device Problem Codes	Structural Problem (2506); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number: d221301 this surgery was with dr.(b)(6) at (b)(6) hospital.During keel preparation, impaction caused a screw to fall out of the impactor handle and into the knee.The surgeon was able to retrieve the fallen screw.This incident did not cause any delay to the surgery and did not have any effect on the patient.The handle was returned with one screw (see image (b)(4)).It is assumed that the screw within the handle is not the same one that fell out during the procedure.From this observation the failure mode is assumed to be that the fallen screw was loose.A design change that constrains the screws within the handle has been implemented to prevent this failure mode per (b)(4) (ed-07827 rev ag).Note: upon further investigation, the handle proved to still be functioning as expected.Additionally, the button and spring did not show any damage (see image (b)(4)).One thing to note is that the screw that had not fallen out of the handle was easily turned loose.It showed little signs of loctite, but did have a bit of red discoloration towards the bottom of the threads, making it seem as if there was some loctite left keeping it in place.This lot was part of recall rc-22-002 (res# 91376).However, while all handles were accounted for, not all the handles were return.Distributors attested that any un-accounted for handles assigned to them were destroyed or scrapped or no longer in their possession.The design fmea for this device, fmea-02696 rev aj, was reviewed.The reported failure mode is captured by row 264: screw falls out into joint.A field action has been opened from previous reports of this failure mode.A design change has already been implemented to reduce or eliminate the occurrence of this failure mode.Testing was conducted to support this change.
Event or Problem Description
The impactor handle screw came out.

• Brand Name: IMPACTOR HANDLE REUSABLE INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONFORMIS; 600 technology park drive; fourth floor; billerica MA 01821
• Manufacturer (Section G): CONFORMIS; 600 research drive; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 600 technology park drive; fourth floor; billeric, MA 01821
• MDR Report Key: 19172822
• Report Number: 3004153240-2024-00009
• Device Sequence Number: 12621418
• Product Code: LXH
• UDI-Device Identifier: 00810933030582
• UDI-Public: 00810933030582
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/24/2024

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: D221301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES-91376
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown