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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH® LONG-HD ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. ANSPACH® LONG-HD ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number LONG-HD
Device Problems Break (1069); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2018
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
We finished burring the femur and had just started to burr the tibia when the anspach started to back out of the end effector.We ended up taking the anspach completely out and realized that the hd long was broken.This was after a good rio registration and burr check.Case type: pka.
 
Manufacturer Narrative
Reported event: we finished burring the femur and had just started to burr the tibia when the anspach started to back out of the end effector.We ended up taking the anspach completely out and realized that the hd long was broken.This was after a good rio registration and burr check.Case type: pka.Product evaluation and results: visual inspection (see attachments) the collar and shaft of the attachment became separated.No observation of damage or handling issues with the attachment.Dimensional inspection not performed as the anspach hd long attachment is an oem product.Material analysis not performed as this device is an oem product.Functional inspection not performed as the failure mode of the separated attachment was confirmed through visual inspection.Product history review: not performed as the device is an oem product complaint history review: a review of complaints in trackwise related to p/n 110920 or long-hd, s/n (b)(4), shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode of separated device making the device unusable is confirmed.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.
 
Event Description
We finished burring the femur and had just started to burr the tibia when the anspach started to back out of the end effector.We ended up taking the anspach completely out and realized that the hd long was broken.This was after a good rio registration and burr check.Case type: pka.
 
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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 Key8193242
MDR Text Key131309083
Report Number3005985723-2018-00771
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K080802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLONG-HD
Device Lot NumberK11311484803
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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