MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNK_OFL

Device Problems Fracture (1260); Insufficient Information (3190)

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

Event Date 11/22/2019

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

Array but broke off in female end of adaptor.Now nut is stuck.Hospital will not release additional info.Case type: tka.Surgical delay : <= 15 minutes.

Event Description

Array but broke off in female end of adaptor.Now nut is stuck.Hospital will not release additional info.Case type: tka.Surgical delay : <= 15 minutes.

Manufacturer Narrative

Update to d2.Reported event: array but broke off in female end of adaptor.Now nut is stuck.Hospital will not release additional info.Case type: tka.Surgical delay : <= 15 minutes.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the product history records cannot be conducted as lot number is not provided.Complaint history review: review of the complaint history records cannot be conducted as lot number is not provided.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.H3 other text : device not returned.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9498365
• MDR Text Key: 190639085
• Report Number: 3005985723-2019-00911
• Device Sequence Number: 1
• Product Code: OLO
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 104