MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL ARRAY POST ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Model Number	160245
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
Pin of end effector attachment broke.Case type: tha.Surgical delay: 15 minutes.
Event or Problem Description
Pin of end effector attachment broke.Case type: tha.Surgical delay : <= 15 minutes.
Additional Manufacturer Narrative
Reported event: pin of end effector attachment broke.Product evaluation and results: as per the image provided in the communication log , the broken cross pin can be seen and confirmed, though the device has not been returned for inspection.Product history review: review of the device history records indicate (b)(4) were manufactured and 30 were rejected on 01/21/2019.A review of qt19 - 01- 0072 revealed that the non- conformance was related to the wrong bar code.A review of qt19 - 01- 0072 revealed that the non conformance is not related to the failure alleged in the complaint.Review of the device history records indicate (b)(4) were manufactured and 66 were rejected on 07/14/2019.A review of qt19 - 08- 0058 revealed that all the devices were accepted to be use as is on 08/16/2019.A review of qt19 - 08- 0058 revealed that the non conformance is not related to the failure alleged in the complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 160245, l/n w60290 shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could be determined via visual inspection of the image provided in the communication log.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

• Brand Name: FEMORAL ARRAY POST ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9722488
• Report Number: 3005985723-2020-00092
• Device Sequence Number: 14270428
• Product Code: OLO
• UDI-Device Identifier: 00848486003142
• UDI-Public: 00848486003142
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• 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): 04/22/2020

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: 160245
• Device Catalogue Number: 160245
• Device Lot Number: W60290
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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: Hospitalization