MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180734-1
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Wrong size onlay tibial insert was inserted into patient.I wrongly grabbed a size 4 insert instead of size 5 and showed boxes to nurse before opening, surgeon refused to look at boxes to confirm.This resulted in wrong size being put in patient.Both assistant and surgeon didn¿t pick up the size difference on insertion and proceeded with closing the incision.While assistant stitched up, surgeon unscrubbed & looked at patient stickers realizing wrong sizes on labels.Surgeon rescrubbed & i grabbed correct size which was inserted and wrong one discarded.Surgical delay of 10 minutes to change the insert.
Event or Problem Description
Wrong size onlay tibial insert was inserted into patient.I wrongly grabbed a size 4 insert instead of size 5 and showed boxes to nurse before opening, surgeon refused to look at boxes to confirm.This resulted in wrong size being put in patient.Both assistant and surgeon didn¿t pick up the size difference on insertion and proceeded with closing the incision.While assistant stitched up, surgeon unscrubbed & looked at patient stickers realizing wrong sizes on labels.Surgeon rescrubbed & i grabbed correct size which was inserted and wrong one discarded.Surgical delay of 10 minutes to change the insert.
Additional Manufacturer Narrative
Reported event: an event regarding user error involving a insert was reported.The event was confirmed based in implant sheet.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 21 sept 2020 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: no further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened h3 other text : device not returned.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10791537
• Report Number: 3005985723-2020-00345
• Device Sequence Number: 3773330
• Product Code: NPJ
• UDI-Device Identifier: 00848486016494
• UDI-Public: 00848486016494
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 180734-1
• Device Catalogue Number: 180734-1
• Device Lot Number: 8H455J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 01/14/2021
• 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: Required Intervention
• Patient Age: 81 YR