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

Model Number 111653

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

Reported event: during mako tha procedure the patients wound was closed with the 3.5mm checkpoint still in the trochanter.The post op x-ray made the surgeon and staff aware.The patient was brought back into or to have the checkpoint removed.Product evaluation and results: product inspection was not performed as no evidence is provided for investigating.Product history review: product history review cannot be conducted as the lot number is not provided.Complaint history review: complaint history review cannot be conducted as the lot number is not provided.Conclusions: the failure cannot be determined as no evidence is provided for investigating.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.

Event Description

During mako tha procedure the patients wound was closed with the 3.5mm checkpoint still in the trochanter.The post op x-ray made the surgeon and staff aware.The patient was brought back into or to have the checkpoint removed.

Manufacturer Narrative

Reported event: during mako tha procedure the patients wound was closed with the 3.5mm checkpoint still in the trochanter.The post op x-ray made the surgeon and staff aware.The patient was brought back into or to have the checkpoint removed.Product evaluation and results: product inspection was not performed as no evidence is provided for investigating.Product history review: product history review cannot be conducted as the lot number is not provided.Complaint history review: complaint history review cannot be conducted as the lot number is not provided.Conclusions: the failure cannot be determined as no evidence is provided for investigating.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text: device not available.

Event Description

During mako tha procedure the patients wound was closed with the 3.5mm checkpoint still in the trochanter.The post op x-ray made the surgeon and staff aware.The patient was brought back into or to have the checkpoint removed.

• Brand Name: CHECKPOINT, 3.5 HEX IMPACTION STERILE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11618456
• MDR Text Key: 253505103
• Report Number: 3005985723-2021-00061
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 111653
• Device Catalogue Number: 111653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention