MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL BASEPLATE STD RM/LL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	170615
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	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size).There was "rm/ll size 5" but it was actually size 6 shape.
Additional Manufacturer Narrative
Reported event: an event regarding size/fit issue involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.See attached results.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that "during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size) (there was "rm/ll size 5" that was actually size 6 shape".Visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.An nc was raised to address this event.Product surveillance will continue to monitor for trends.
Event or Problem Description
It was reported that during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size).There was "rm/ll size 5" but it was actually size 6 shape.
Additional Manufacturer Narrative
Reported event: an event regarding size/fit issue involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.See attached results.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that "during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size) (there was "rm/ll size 5" that was actually size 6 shape".Visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.Nc was raised to address this event.A classification letter from the fda has not been received; once the classification letter is received, a supplemental will be sent with the recall number.

• Brand Name: TIBIAL BASEPLATE STD RM/LL SIZE 5
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16385250
• Report Number: 3005985723-2023-00035
• Device Sequence Number: 5618160
• Product Code: NPJ
• UDI-Device Identifier: 00848486003746
• UDI-Public: 00848486003746
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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: 170615
• Device Catalogue Number: 170615
• Device Lot Number: 26270421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PFA 3194049
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown