MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 210080

Device Problems Material Frayed (1262); Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

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 Description

Splinter in boot, hospital will not keep.Case type: tka.

Event Description

Splinter in boot, hospital will not keep.Case type: tka.

Manufacturer Narrative

Follow-up #1 and final report submitted.Reported event: it was reported that splinter in boot, hospital will not keep it.Case type: tka.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Capa: 2127499 has been raised for the same.Product history review: review of the product history records was attempted but the provided lot#: 201843030601, did not reveal any manufactured or accepted final stock conformance's or inspection records.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 210080, lot number: 201843030601 shows 0 additional complaints related to the failure in this investigation.Conclusions: 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 : product was not available for evaluation.

• Brand Name: BOOT ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8757726
• MDR Text Key: 149940987
• Report Number: 3005985723-2019-00484
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210080
• Device Lot Number: 201843030601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization