MAUDE Adverse Event Report: MAKO SURGICAL CORP. OFFSET CUP REAMER HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 212760

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2022

Event Type  Injury  

Event Description

It was reported that the offset reamer handle screw came off and was left in the patient."we had a patient that needed to have a second surgery to remove a screw that was left behind in the hip.After inspecting the reamer handle we noticed that a screw was missing.Today after inspecting another reamer handle my colleague noticed that also in that one screws are missing".

Manufacturer Narrative

Reported event: the end user reported that the offset reamer handle screwed off.Product evaluation and results: product inspection could not be performed as the product was not returned for evaluation.Product history review: review of the product history records indicate devices were manufactured and accepted into final stock without any discrepancies.Complaint history review: a review of complaints shows 0 additional complaints related to the failure in this investigation.Conclusion: the failure could not be determined as the product was not returned for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Manufacturer Narrative

Reported event: it was reported that the offset reamer handle screw came off and was left in the patient.Product evaluation and results: an image of the device has been provided, the alleged failure of the disassociated screw can be determined however the product was not evaluated as the product was unavailable for inspection.If additional information is received, then the complaint will be reopened.Product history review: review of the product history records indicate devices were manufactured and accepted into final stock without any discrepancies.Complaint history review: a review of complaints shows 0 additional complaints related to the failure in this investigation.Conclusion: the failure could be determined via inspection of the image provided however the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

It was reported that the offset reamer handle screw came off and was left in the patient."we had a patient that needed to have a second surgery to remove a screw that was left behind in the hip.After inspecting the reamer handle we noticed that a screw was missing.Today after inspecting another reamer handle my colleague noticed that also in that one screws are missing".

• Brand Name: OFFSET CUP REAMER HANDLE
• Type of Device: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13405230
• MDR Text Key: 285169738
• Report Number: 3005985723-2022-00011
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032142
• UDI-Public: 00848486032142
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

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: 212760
• Device Catalogue Number: 212760
• Device Lot Number: 5053600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention