MAUDE Adverse Event Report: MAKO SURGICAL CORP. IMPACTOR-ONLAY INSERT; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	160405
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
Bad condition.Case type: pka.Update: "the surgeon noticed the tip of the impactor was chipped/chipping.She asked that it be replaced".
Additional Manufacturer Narrative
H1 type of reportable event initial mistakenly reported as serious injury, correcting to malfunction.An event regarding damage involving a mako impactor was reported.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Conclusion: no product was returned for evaluation.The device was discovered prior to medical procedure.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.No further investigation is required at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Bad condition.Case type: pka.Update: "the surgeon noticed the tip of the impactor was chipped/chipping.She asked that it be replaced".

• Brand Name: IMPACTOR-ONLAY INSERT
• 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: 8934921
• Report Number: 3005985723-2019-00602
• Device Sequence Number: 617800
• Product Code: NPJ
• UDI-Device Identifier: 00848486003203
• UDI-Public: 00848486003203
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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 Catalogue Number: 160405
• Device Lot Number: 12080111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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