MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY STABILIZER, SHORT, 4.0MM; STEREOTAXIC DEVICE, ROBOTICS

Model Number	112680
Medical Device Problem Codes	Difficult to Remove (1528); Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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
4.0 x 110mm pin became stuck in the short 4.0 array stabilizer when the surgeon attempted to remove the pin from the bone.The pin was removed from the bone by manually.Case type: tka.
Additional Manufacturer Narrative
Reported event: 4.0 x 110mm pin became stuck in the short 4.0 array stabilizer when the surgeon attempted to remove the pin from the bone.The pin was removed from the bone manually.Method & results: device evaluation and results: not performed as no items were returned.Product history review: review of the device history records indicates (b)(4) device(s) were manufactured and accepted into final stock on 11/02/2018 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 112680, lot: 19560418 shows 1 additional complaint(s) related to the failure in this investigation.(b)(4).Conclusion: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint 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.H3 other text: device not returned.
Event or Problem Description
4.0 x 110mm pin became stuck in the short 4.0 array stabilizer when the surgeon attempted to remove the pin from the bone.The pin was removed from the bone by manually.Case type: tka.

• Brand Name: ARRAY STABILIZER, SHORT, 4.0MM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9566584
• Report Number: 3005985723-2020-00008
• Device Sequence Number: 2936948
• Product Code: OLO
• UDI-Device Identifier: 00848486017903
• UDI-Public: 00848486017903
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• 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): 03/09/2020

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: 112680
• Device Catalogue Number: 112680
• Device Lot Number: 19560418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/09/2020
• 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: Other