MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® STRAIGHT SHELL IMPACTOR,TRIDENT PST STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209820

Device Problems Contamination /Decontamination Problem (2895); Non Reproducible Results (4029)

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

Event Date 06/05/2019

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

Impactor containing bio burden after sterilization. Case type: tha. Surgical delay
=
15 minutes.

Event Description

Impactor containing bio burden after sterilization. Case type: tha. Surgical delay:
=
15 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted based on the results of investigation. Reported event: it was reported that the impactor contains bio burden after sterilization. Product evaluation and results: product inspection could not be performed as the product was not available for evaluation. Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot 33781 and accepted into final stock on 10/03/2016. No non-conformances were identified during inspection. Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209820, lot 33781, shows no 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 ncs or capas associated with the product and failure mode reported in this event. H3 other text : product was not available for evaluation.

• Brand Name: RIO® STRAIGHT SHELL IMPACTOR,TRIDENT PST
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8723982
• Report Number: 3005985723-2019-00451
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030278
• UDI-Public: 00848486030278
• Combination Product (y/n): N
• PMA/PMN Number: K141989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 209820
• Device Lot Number: 33781
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Hospitalization