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

Model Number 210080

Device Problem Material Frayed (1262)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2020

Event Type  malfunction  

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 Description

Black boot is starting to fray near the toe, causing splinters.Case type: tka.

Event Description

Black boot is starting to fray near the toe, causing splinters.Case type: tka.

Manufacturer Narrative

Reported event: black boot is starting to fray near the toe, causing splinters.Product inspection : visual inspection confirms the boot assembly has splintered along the edges.See attached for visual confirmation.Product history review: review of the device history records indicate (b)(4) were manufactured and (b)(4) accepted into final stock on 07/06/2018.Review revealed that a non-conformance is not related to the failure alleged in this compliant.Additionally (b)(4) was manufactured and accepted into final stock on 08/10/2018 with no reported discrepancies.Complaint history review a review of complaints related to p/n: 210080, lot number: 201843042205, shows 03 additional complaint(s) related to the failure in this investigation.Conclusion: 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.The failure was confirmed as alleged via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: BOOT ASSEMBLY
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9806218
• MDR Text Key: 182574051
• Report Number: 3005985723-2020-00144
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201843042205
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other