MAUDE Adverse Event Report: MAKO SURGICAL CORP. TKA FORCE BALANCER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	164206
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Gap balancer broke during gap balancing.Case type: tka.
Event or Problem Description
Gap balancer broke during gap balancing.Case type: tka.
Additional Manufacturer Narrative
Product available to stryker.An event regarding crack/fracture involving a mako other instrument was reported.The event was not confirmed.Product evaluation and results: not performed as no product was returned.Clinician review: not performed as no medical records were received for evaluation.Review of the product 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.The exact cause of the event could not be determined because further information is required such as return of the device.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TKA FORCE BALANCER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7803940
• Report Number: 3005985723-2018-00505
• Device Sequence Number: 1909190
• Product Code: OLO
• UDI-Device Identifier: 00848486029784
• UDI-Public: 00848486029784
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K143752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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 Catalogue Number: 164206
• Device Lot Number: ERDNJ7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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