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

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.

• 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 Key: 8196911
• MDR Text Key: 131490376
• Report Number: 3005985723-2018-00780
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (y/n): N
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• 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 Number: 111653
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization