MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH® LONG-HD ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number LONG-HD

Device Problems Contamination (1120); Non Reproducible Results (4029)

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

Event Date 04/19/2019

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

During burring the surgeon complained of the anspach long attachment getting hot.It was also making an unusually loud noise.The case was able to be completed as normal.After the case, when the end effector was taken apart, there was some black liquid inside the long-hd.Also appeared as if the inner bearing was worn out.Would like to receive several new attachments so i can proactively replace some older ones at this account.Case type: pka.

Manufacturer Narrative

Reported event: during burring the surgeon complained of the anspach long attachment getting hot.It was also making an unusually loud noise.The case was able to be completed as normal.After the case, when the end effector was taken apart, there was some black liquid inside the long-hd.Also appeared as if the inner bearing was worn out.Would like to receive several new attachments so i can proactively replace some older ones at this account.Case type: pka.Product evaluation and results: no device inspection could be completed as the product was not available for evaluation.Product history review: product history review was not performed as it is an oem product.Complaint history review: a review of complaints in catsweb and trackwise related to p/n long-hd, s/n (b)(6) shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard h3 other text : product was not available for evaluation.

Event Description

During burring the surgeon complained of the anspach long attachment getting hot.It was also making an unusually loud noise.The case was able to be completed as normal.After the case, when the end effector was taken apart, there was some black liquid inside the long-hd.Also appeared as if the inner bearing was worn out.Would like to recieve several new attachments so i can proactively replace some older ones at this account.Case type: pka.

• Brand Name: ANSPACH® LONG-HD ATTACHMENT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8594659
• MDR Text Key: 144572111
• Report Number: 3005985723-2019-00352
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LONG-HD
• Device Lot Number: SNH39309920908
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 136