MAUDE Adverse Event Report: MAKO SURGICAL CORP. SLED ASSEMBLY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	210110
Medical Device Problem Codes	Mechanical Problem (1384); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
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
Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.
Additional Manufacturer Narrative
Reported issue.Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.Product inspection : product inspection could not be performed as the product was not made available for evaluation within 60 days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the product becomes available for inspection.Product history review.Review of the device history records indicate 25 devices were manufactured and accepted into final stock on 12/02/2016.No non-conformances were identified during inspection.Complaint history review.A review of complaints related to p/n 210110, lot 19400616 shows 3 additional complaint(s) related to the failure in this investigation.Conclusion.The alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.¿.
Event or Problem Description
Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.
Additional Manufacturer Narrative
Reported issue.Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.Product inspection : functional inspection confirms the ball moves when tested with a known good boot assembly when in the locked position, confirming the alleged failure.Product history review.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 12/02/2016.No non-conformances were identified during inspection.Complaint history review a review of complaints related to p/n 210110, lot 19400616 shows 3 additional complaint(s) related to the failure in this investigation.Conclusion the alleged failure was confirmed via inspection.No additional investigation or specific actions are required.¿.
Event or Problem Description
Setting up for a mako pka case, dr was assembling the mako leg positioner onto the bed and patient leg.When dr placed the boot & patient leg into the sled- the leg positioner sled would not hold the weight of the leg in position.The leg would keep falling lateral whenever the leg was let go by the surgeon.No delays to surgery, surgery was completed by assistant manually holding the leg in place to support it.

• Brand Name: SLED ASSEMBLY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10828809
• Report Number: 3005985723-2020-00358
• Device Sequence Number: 16869857
• Product Code: OLO
• UDI-Device Identifier: 00848486031848
• UDI-Public: 00848486031848
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2021

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: 210110
• Device Catalogue Number: 210110
• Device Lot Number: 19400616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 03/18/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/22/2021; 04/12/2021
• 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
• Patient Age: 62 YR
• Patient Weight: 120