MAUDE Adverse Event Report: ENGAGE UNI LLC ENGAGE SURGICAL PARTIAL KNEE SYSTEM 3.2MM THREADED PIN

Model Number	1-50100-455
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was requested for evaluation, but was not able to be returned.The exact cause of the event could not be confirmed from the information available and without device evaluation.The surgeon indicated that the pin may have been skiving off of the bone when inserting into the femur.During the investigation of the event, it was discovered that the pins may have been reused.Per the labeling, the pins are single-use and are to be disposed of after each use.If the pin had been reused, the tip may not have been as sharp resulting in it skiving off the bone.This would cause additional stress to the pin, which may result in fracture.
Event or Problem Description
It was reported that a 3.2mm pin broke during a procedure.The pin sheared off at the surface of the femur when trying to remove.The surgeon decided to leave the piece of the pin in the patient because attempting to remove it might cause harm to the patient.No delay in procedure.No adverse consequences from the event were reported.

• Brand Name: ENGAGE SURGICAL PARTIAL KNEE SYSTEM 3.2MM THREADED PIN
• Common Device Name: 3.2MM THREADED PIN
• Manufacturer (Section D): ENGAGE UNI LLC; 3505 lake lynda dr; suite 206; orlando FL 32817
• MDR Report Key: 11311143
• Report Number: 3016249968-2021-00001
• Device Sequence Number: 11795421
• Product Code: NJD
• UDI-Device Identifier: B6951501004550
• UDI-Public: +B6951501004550/$$7200225E
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: No Information
• Device Model Number: 1-50100-455
• Device Catalogue Number: 1-50100-455
• Device Lot Number: 200225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/10/2021
• 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: Other
• Patient Age: 50 YR