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 Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.Not returned.
Event or Problem Description
Poly impactor is very rigid on the tip due to hitting implant/metal.Case type: pka.
Event or Problem Description
Poly impactor is very rigid on the tip due to hitting implant/metal.Case type: pka.
Additional Manufacturer Narrative
Corrected data: expiration date provided in error, on initial mdr.As device is a reusable instrument, expiration date does not apply; an event regarding damage involving a mako impactor was reported.Conclusion: it was reported that the poly impactor was very rigid on the tip due to hitting implant/metal.Visual inspection of the available image of the device noted that heavy dent marks are observed on the surface of the device.The device was not returned.The device was discovered during inspection.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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: 7754401
• Report Number: 3005985723-2018-00460
• Device Sequence Number: 1171222
• Product Code: NPJ
• UDI-Device Identifier: 00848486003203
• UDI-Public: 00848486003203
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/24/2018

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 Expiration Date: 12/31/2021
• Device Catalogue Number: 160405
• Device Lot Number: 12221116
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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