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

Model Number	111653
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11618456
• Report Number: 3005985723-2021-00061
• Device Sequence Number: 3262753
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 111653
• Device Catalogue Number: 111653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention