MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIP END EFFECTOR, VARIABLE ANGLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	206967
Medical Device Problem Codes	Failure to Calibrate (2440); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
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
Hip ee is part of a recall.Case type / application: tha.
Additional Manufacturer Narrative
Reported issue ¿ hip ee is part of a recall.Case type / application: (b)(4).Product inspection ¿ the failure is confirmed as it is under the scope of nc hip end effectors (p/n 206967) failed characterization values.Also the serial number (b)(6) lies in the medical device recall list.Product history review - review of the device history records indicate 46 devices were manufactured under p/n 206967 lot 19330219 and 39 were accepted (including (b)(6) into final stock on 26 mar 2020.Review of qt revealed the reason for rejection was not related to the failure in this investigation.Complaint history review ¿ a review of complaints in catsweb and trackwise related to p/n 206967 lot 19330219 shows 00 additional complaints related to the failure in this investigation.Nc/capa history review - a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.Conclusion ¿ the event was confirmed because the serial number (b)(6) lies in the medical device recall list corresponding to nc.If additional information is received, then the complaint will be reopened.Per preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved, and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are required.
Event or Problem Description
Hip ee is part of a recall.Case type / application: (b)(4).

• Brand Name: HIP END EFFECTOR, VARIABLE ANGLE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11012675
• Report Number: 3005985723-2020-00389
• Device Sequence Number: 11902860
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 03/08/2021

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: 206967
• Device Catalogue Number: 206967
• Device Lot Number: 1905387
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2745-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other