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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 111653
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2018
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
Stryker rep reported that, prior to closing the patients incision, the greater trochanter checkpoint was removed (111653) followed by the pelvic checkpoint (111653) ¿ on inspection of the pelvic checkpoint it was noticed that the pin section was missing.An x-ray was carried out showing that the pin was remaining inside the patients bone.Mr conroy (surgeon) proceeded with surgical intervention to remove it.This caused a delay of around 30 minutes to the operative time.Unfortunately the checkpoint was discarded by mistake after requesting it was kept.The checkpoints that were used in this case were 2x 111653 3.5 hex impaction checkpoints with 1 failing.
 
Event Description
Stryker rep reported that, prior to closing the patients incision, the greater trochanter checkpoint was removed (111653) followed by the pelvic checkpoint (111653) ¿ on inspection of the pelvic checkpoint it was noticed that the pin section was missing.An x-ray was carried out showing that the pin was remaining inside the patients bone.Mr conroy (surgeon) proceeded with surgical intervention to remove it.This caused a delay of around 30 minutes to the operative time.Unfortunately the checkpoint was discarded by mistake after requesting it was kept.The checkpoints that were used in this case were 2x 111653 3.5 hex impaction checkpoints with 1 failing.
 
Manufacturer Narrative
Reported event: stryker rep reported that, prior to closing the patients incision, the greater trochanter checkpoint was removed (111653) followed by the pelvic checkpoint (111653) ¿ on inspection of the pelvic checkpoint it was noticed that the pin section was missing.An x-ray was carried out showing that the pin was remaining inside the patients bone.Mr conroy (surgeon) proceeded with surgical intervention to remove it.This caused a delay of around 30 minutes to the operative time.Tha unfortunately the checkpoint was discarded by mistake after requesting it was kept.The checkpoints that were used in this case were 2x 111653 3.5 hex impaction checkpoints with 1 failing.Product evaluation and results: device unavailable for inspection.Product history review: a review of the device history records could not be performed as the lot was not provided.Complaint history review: a review of the complaint history could not be performed as the lot was not provided.Conclusions: no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation 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.
 
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Brand Name
CHECKPOINT, 3.5 HEX IMPACTION STERILE
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8196911
MDR Text Key131490376
Report Number3005985723-2018-00780
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486017316
UDI-Public00848486017316
Combination Product (y/n)N
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number111653
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/10/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received02/28/2019
Supplement Dates FDA Received03/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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