MAUDE Adverse Event Report: MAKO SURGICAL CORP. CEMENT REMOVAL TOOL; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	120095
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2019
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 returned.
Event or Problem Description
The cement scraper was being used to pick a piece of hard cement off and was bent, upon trying to return it to its normal shape, the end of the scraper broke off.Case type: tka.
Additional Manufacturer Narrative
It was reported that "the cement scraper was being used to pick a piece of hard cement off and was bent, upon trying to return it to its normal shape, the end of the scraper broke off." the event was not confirmed.Method & results: -device evaluation and results: not performed as the device(s) were not available for evaluation.-product history review: review of the device history records indicates (b)(4) were manufactured and accepted into final stock on 17aug2018 with no reported discrepancies.-complaint history review: a review of complaints in catsweb and trackwise related to p/n 120095, lot 06110818 shows 06 additional complaint(s) related to the failure in this investigation.Conclusion: the exact cause of the event could not be determined because the device was not available for evaluation.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by the investigator.If devices and / or additional information become available, this investigation will be reopened.
Event or Problem Description
The cement scraper was being used to pick a piece of hard cement off and was bent, upon trying to return it to its normal shape, the end of the scraper broke off.Case type: tka.

• Brand Name: CEMENT REMOVAL TOOL
• 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: 8658162
• Report Number: 3005985723-2019-00398
• Device Sequence Number: 11337664
• Product Code: NPJ
• UDI-Device Identifier: 00848486018092
• UDI-Public: 00848486018092
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/20/2019

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: 120095
• Device Lot Number: 06110818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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