MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE EVOLUTION PIN PACK 3 LONG & 2 COLLARED S; KNEE INSTRUMENT

Model Number	K0001288
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, collared pin broke off in patient's femur during primary tkr surgery, part remaining in-situ.Part snapped when it locked the block to femur.Incident caused 2 hr delay, no adverse outcome to patient.Additional information received from distributor on 05/24/2021: medical facility information.(b)(6).

• Brand Name: ADVANCE EVOLUTION PIN PACK 3 LONG & 2 COLLARED S
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11925390
• Report Number: 3010536692-2021-00314
• Device Sequence Number: 19791123
• Product Code: LXH
• UDI-Device Identifier: M684K00012881
• UDI-Public: M684K00012881
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: Other
• Device Model Number: K0001288
• Device Catalogue Number: K0001288
• Device Lot Number: 1842063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/12/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 08/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention