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

Model Number	ED-07827
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that we received post-op x-rays today of dr.Jared lee's patient who appears to have had a screw implanted in their tibia along with their conformis implant.The impactor handle that was used during surgery is also missing one of its set screws after review of the post-op x-ray, the sales rep confirmed that the screw on the impaction face of the handle was missing.The handle in question was returned from the rep and inspected.A surgical technique evaluation on how the screw could have dropped into the tibia was investigated.The handle was returned and visually inspected.Visually, there was no evidence of loctite thread locker being applied to the screw.Loctite 272 or equivalent thread locker epoxy is specified in the engineering drawing for ed-07827.This epoxy is used to prevent the screw from loosening due to shock/vibrations and can withstand temperatures up to 450° f, which is much higher than steam sterilization temperature of 270° f.This is intended to be applied by the supplier but appears to have been omitted.There are no visible signs of residue from the epoxy on either the screw or the hole.Next, a new set of screws were attempted to be inserted into the complaint handle holes with an allen key.When reaching full depth, the screw continuously spun with minimal resistance suggesting the threads on the handle were stripped.Thread stripping is a shear failure of an internal or external thread that results when the strength of the threaded material is exceeded by the applied forces acting on the thread.Thread stripping lowers the locking strength of the screw to the hole relative to a non-stripped thread.
Event or Problem Description
It was reported that we received post-op x-rays today of dr.(b)(6) patient who appears to have had a screw implanted in their tibia along with their conformis implant.The impactor handle that was used during surgery is also missing one of its set screws.
Additional Manufacturer Narrative
It was reported that we received post-op x-rays today of dr.(b)(6) patient who appears to have had a screw implanted in their tibia along with their conformis implant.The impactor handle that was used during surgery is also missing one of its set screws after review of the post-op x-ray, the sales rep confirmed that the screw on the impaction face of the handle was missing.The handle in question was returned from the rep and inspected.A surgical technique evaluation on how the screw could have dropped into the tibia was investigated.The handle was returned and visually inspected.Visually, there was no evidence of loctite thread locker being applied to the screw.Loctite 272 or equivalent thread locker epoxy is specified in the engineering drawing for ed-07827.This epoxy is used to prevent the screw from loosening due to shock/vibrations and can withstand temperatures up to 450° f, which is much higher than steam sterilization temperature of 270° f.This is intended to be applied by the supplier but appears to have been omitted.There are no visible signs of residue from the epoxy on either the screw or the hole.Next, a new set of screws were attempted to be inserted into the complaint handle holes with an allen key.When reaching full depth, the screw continuously spun with minimal resistance suggesting the threads on the handle were stripped.Thread stripping is a shear failure of an internal or external thread that results when the strength of the threaded material is exceeded by the applied forces acting on the thread.Thread stripping lowers the locking strength of the screw to the hole relative to a non-stripped thread.
Event or Problem Description
It was reported that we received post-op x-rays today of dr (b)(6) patient who appears to have had a screw implanted in their tibia along with their conformis implant.The impactor handle that was used during surgery is also missing one of its set screws.

• Brand Name: IMPACTOR HANDLE
• Common Device Name: REUSABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): CONFORMIS INC; 600 technology park drive; billerica 01821
• Manufacturer Contact: elizabeth haines ; 600 technology park dr; billerica 01821
• MDR Report Key: 16064547
• Report Number: 3004153240-2022-00178
• Device Sequence Number: 6186493
• Product Code: LXH
• UDI-Device Identifier: 00810933030582
• UDI-Public: 00810933030582
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Repair,Notification,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: ED-07827
• Device Lot Number: D221301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown