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

Catalog Number	210080
Medical Device Problem Codes	Material Frayed (1262); Sharp Edges (4013)
Health Effect - Clinical Codes	Blister (4537); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
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
The edge of the plastic has been fraying and has cut staff to the point of bleeding case type / application: (b)(4).
Additional Manufacturer Narrative
An event regarding splinter involving a mako leg holder was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a product history review is not required, as no manufacturing specific issue has been alleged.At stryker joint replacement all devices/product are manufactured through validated equipment and inspected by trained representatives through stryker¿s quality management system.Complaint history review: a complaint history review and trend detection is not required as this is a pm.Monitoring will be continued under the current quarterly trend review.Conclusions: no actual or potential patient harm existed for the alleged event.The alleged failure mode was not confirmed because 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.H3 other text : not available.
Event or Problem Description
The edge of the plastic has been fraying and has cut staff to the point of bleeding case type / application: tka.

• Brand Name: BOOT ASSEMBLY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18168176
• Report Number: 3005985723-2023-00174
• Device Sequence Number: 20488556
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 210080
• Device Lot Number: 201843090932
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown