MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	210080
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
Dr (b)(6) was using the mako tkr leg holder as part of his usual mako tkr procedure.During implantation (impaction) of the tibial baseplate, the boot snapped off the bracket that holds the stainless steel cone peg, causing the leg to drop suddenly.No injury was sustained to the patient or the surgeon, however the leg holder is broken from standard use.Update 18 august 2020: 2-3 minute surgical delay as they adjusted position manually to position the leg for the tibial implantation and skin closure.
Additional Manufacturer Narrative
Reported event: the doctor was using the mako tkr leg holder as part of his usual mako tkr procedure.During implantation (impaction) of the tibial baseplate, the boot snapped off the bracket that holds the stainless steel cone peg, causing the leg to drop suddenly.No injury was sustained to the patient or the surgeon, however the leg holder is broken from standard use.Update 18 august 2020: 2-3 minute surgical delay as they adjusted position manually to position the leg for the tibial implantation and skin closure.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the device history records indicates 18 device(s) were manufactured and accepted into final stock on 07.27.2017 with no reported discrepancies.Review of the device history records also indicates 01 device(s) were manufactured and accepted into final stock on 10.30.2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, l/n 201743072002 shows 1 additional complaint(s) related to the failure in this investigation.Conclusion: the failure was not determined as device was not returned for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Dr (b)(6) was using the mako tkr leg holder as part of his usual mako tkr procedure.During implantation (impaction) of the tibial baseplate, the boot snapped off the bracket that holds the stainless steel cone peg, causing the leg to drop suddenly.No injury was sustained to the patient or the surgeon, however the leg holder is broken from standard use.Update 18 august 2020: 2-3 minute surgical delay as they adjusted position manually to position the leg for the tibial implantation and skin closure.

• Brand Name: BOOT ASSEMBLY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10474872
• Report Number: 3005985723-2020-00290
• Device Sequence Number: 2391918
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201743072002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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
• Patient Weight: 190