MAUDE Adverse Event Report: ENGAGE UNI LLC (DBA ENGAGE SURGICAL) ENGAGE SURGICAL PARTIAL KNEE SYSTEM; TIBIAL ANCHOR GUIDE INSTRUMENT

Model Number	1-50061-002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon indicated that during the procedure it was evident the patient had unusually dense sclerotic bone in the area of implantation.Review of pre-op imaging confirmed this.The area of high-density bone may have resulted in higher than normal impaction forces being applied to the instruments during the implantation of the tibial anchor.The higher forces may have caused the tip of the tibial anchor guide screw to detach.The tibial anchor guide was returned and evaluated.There was no visible defects or flaws in the instrument.
Event or Problem Description
It was reported that during a procedure, the tip of a tibial anchor guide screw broke off while impacting the tibial anchor implant into the tibia.The tibial anchor implantation was completed successfully.The surgeon left the tip of the screw in the tibial tray implant, as it was fully contained inside the mating threaded area of the tibial tray component.No significant delay in procedure and no adverse consequences from the event were reported.

• Brand Name: ENGAGE SURGICAL PARTIAL KNEE SYSTEM
• Common Device Name: TIBIAL ANCHOR GUIDE INSTRUMENT
• Manufacturer (Section D): ENGAGE UNI LLC (DBA ENGAGE SURGICAL); 3505 lake lynda dr; suite 206; orlando FL 32817
• MDR Report Key: 11821281
• Report Number: 3016249968-2021-00004
• Device Sequence Number: 19938494
• Product Code: NJD
• UDI-Device Identifier: B6951500610020
• UDI-Public: +B6951500610020/$$72001448
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• 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): 05/13/2021

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: Health Professional
• Device Model Number: 1-50061-002
• Device Lot Number: 200144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1