MAUDE Adverse Event Report: MAKO SURGICAL CORP. VARIABLE ANGLE CORTICAL SCREW, STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	111655
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The layer was removed and closed using the mako operation, and a postoperative x-ray revealed that only the washer portion remained in the layer.The wound was reopened before patient awakening and the washer was removed.
Additional 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.
Additional Manufacturer Narrative
Reported event: an event regarding other involving a mako screw was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: product history review was not conducted as lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.
Event or Problem Description
The layer was removed and closed using the mako operation, and a postoperative x-ray revealed that only the washer portion remained in the layer.The wound was reopened before patient awakening and the washer was removed.

• Brand Name: VARIABLE ANGLE CORTICAL SCREW, STERILE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15787770
• Report Number: 3005985723-2022-00149
• Device Sequence Number: 12165673
• Product Code: OLO
• UDI-Device Identifier: 00848486017323
• UDI-Public: 00848486017323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 111655
• Device Catalogue Number: 111655
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown